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| Device Problems
Use of Device Problem (1670); Physical Resistance/Sticking (4012)
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| Patient Problems
Abrasion (1689); Injury (2348)
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Event Type
Injury
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Event Description
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Event verbatim [preferred term] it literally removed some skin/skin abrasion [skin abrasion] , the adhesive adheres too tightly [device adhesion issue] , she uses the wraps to control pain for her cervical and lumbar areas [device use issue] ,.Case narrative: this is a spontaneous report from a contactable consumer.A female patient of an unspecified age started to use thermacare heatwrap (thermacare neck, shoulder & wrist) from an unspecified date to control pain for her cervical and lumbar areas.The patient's medical history and concomitant medications were not reported.The patient uses the wraps to control pain for her cervical and lumbar areas on an unspecified date.She also reported the suspect products did work but the adhesive layer either comes off too easily or sticks too tightly and pulls the skin (especially neck area).Upon follow-up the patient reported during one instance it literally removed some skin on an unspecified date.In some instances it hardly holds at all.A second issue which had only happened once was the strip did not heat.She also reported "the product should not cause skin abrasion especially if your research/ lab people can determine an easy fit".No hospitalization was needed for the events.Action taken with the suspect product was unknown.Clinical outcome of the events was unknown.Additional information has been requested and will be provided as it becomes available.Follow up (05apr2016): new information received from a contactable consumer included the product complaint verbatim "the adhesive layer either comes off too easily or sticks to tightly and pulls the skin (especially neck area)." follow-up (14jun2016): new information received from a contactable consumer included reaction data (additional event of removed some skin/skin abrasion) and the product complaint verbatim the strip did not heat.Follow-up (14jun2016): this follow-up report is being submitted to upgrade this case to a reportable mdr.Company clinical evaluation comment: based on the information provided, the events skin abrasion and device adhesion issue as described is considered serious bodily injury potentially requiring medical intervention to prevent permanent damage or impairment of body structure.Event device use issue is non-serious.The events are medically assessed as associated with the use of the device., comment: based on the information provided, the events skin abrasion and device adhesion issue as described is considered serious bodily injury potentially requiring medical intervention to prevent permanent damage or impairment of body structure.Event device use issue is non-serious.The events are medically assessed as associated with the use of the device.
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Manufacturer Narrative
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Sterile product: no.Samples available: unknown.Reasonably suggest device malfunction: yes.Severity of harm: s1.Class: product use attributes.Sub class: wrap/patch/pad never worked/unusable/cannot be reused.Class: external cause investigation.Sub class: adverse event safety request for investigation.Was capa previously identified: yes.Capas in place: no.Process related: no.Final confirmation status: not confirmed.Root cause category (tier 1): equipment.Reserve sample evaluation and testing required.N.Lot-specific trend and expedited trend identified: no.Lot trend assessment & rationale: refer to evaluation of complaints related to open pouches.Sample status: not requested.Site sample status: not received.There was no impact on regulatory, product quality, and market/clinical and stability.Evaluation of complaints related to open pouches (never worked, squeeze tube did not last long enough and too cool): introduction: thermacare heat wraps are premium topical heat therapy products.They function by producing a long lasting therapeutic heat through the controlled oxidation of iron.Primary packaging sealing stops the oxidation process until the consumer opens the wrapped product.The heat wraps are worn against the body or over a layer of clothing to relieve minor muscular and joint aches and pains.The (site name) is the sole manufacturing location for thermacare heat wraps.They are produced on two manufacturing lines; the b line produces the larger products which wrap around the body with stretch materials, and the m line produces the smaller products that are attached for use with pressure sensitive adhesives.The purpose of this document is to summarize customer complaint investigations where the pouch seal (primary packaging) of a thermacare wrap does not seal properly.When the pouch seal is not integral oxygen will enter the pouch and allow the iron oxidation reaction to proceed through completion.Once the reaction is complete the wrap will.
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Event Description
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Event verbatim [preferred term] it literally removed some skin/skin abrasion [skin abrasion] , the adhesive adheres too tightly [device adhesion issue] , she uses the wraps to control pain for her cervical and lumbar areas [device use issue].Case narrative:this is a spontaneous report from a contactable consumer.A female patient of an unspecified age started to use thermacare heatwrap (thermacare neck, shoulder & wrist) from an unspecified date to control pain for her cervical and lumbar areas.The patient's medical history and concomitant medications were not reported.It was reported "the suspect products did work but the adhesive layer either comes off too easily or sticks too tightly/adheres to tightly and pulls the skin (especially neck area).During one instance it literally removed some skin on an unspecified date.In some instances it hardly holds at all.A second issue which had only happened once was the strip did not heat, never heats up properly".Also reported, "the product should not cause skin abrasion especially if your research".No hospitalization was needed for the events.Action taken with the suspect product was unknown.Clinical outcome of the events was unknown.On 16nov2019, the following investigation findings was provided from product quality complaint: sterile product: no.Samples available: unknown.Reasonably suggest device malfunction: yes.Severity of harm: s1.Class: product use attributes.Sub class: wrap/patch/pad never worked/unusable/cannot be reused.Class: external cause investigation.Sub class: adverse event safety request for investigation.Was capa previously identified: yes.Capas in place: no.Process related: no.Final confirmation status: not confirmed.Root cause category (tier 1): equipment.Reserve sample evaluation and testing required.N.Lot-specific trend and expedited trend identified: no.Lot trend assessment & rationale: refer to evaluation of complaints related to open pouches.Sample status: not requested.Site sample status: not received.There was no impact on regulatory, product quality, and market/clinical and stability.Evaluation of complaints related to open pouches (never worked, squeeze tube did not last long enough and too cool): introduction: thermacare heat wraps are premium topical heat therapy products.They function by producing a long lasting therapeutic heat through the controlled oxidation of iron.Primary packaging sealing stops the oxidation process until the consumer opens the wrapped product.The heat wraps are worn against the body or over a layer of clothing to relieve minor muscular and joint aches and pains.The (site name) is the sole manufacturing location for thermacare heat wraps.They are produced on two manufacturing lines; the b line produces the larger products which wrap around the body with stretch materials, and the m line produces the smaller products that are attached for use with pressure sensitive adhesives.The purpose of this document is to summarize customer complaint investigations where the pouch seal (primary packaging) of a thermacare wrap does not seal properly.When the pouch seal is not integral oxygen will enter the pouch and allow the iron oxidation reaction to proceed through completion.Once the reaction is complete the wrap will no longer produce heat.When the wrap is opened by a customer for use no heat will be generated.Consumer complaints of this type come back for evaluation in the subclasses of never worked, did not last long enough, squeeze tube - open pouch, and too cool.This document will summarize this well-known defect, root cause, identified action items and a process to evaluate incoming complaints of this nature in order to determine the degree and provide justification when no investigation is needed.Severity of this defect aligns with s1: inconvenient, annoying but no harm.Pouch sealing investigations and root cause: in 2013 a complaint trend was opened for the pouch seal defect (major aql of 1.5).The trend directly correlates with the implementation of ultrasonic heat seal technology (replace heat seal technology).Since 2013 complaints for this defect have continued to increase at the site.Complaint investigations for pouch sealing are well characterized due to the number of investigations completed over the years.Pack technology and inspection is the name of the equipment used to determine the presence of leaks in thermacare heat wrap pouches.Pouches are placed in a test chamber and a known vacuum is applied.The resulting pressure loss is compared to a reference pressure.The changes in absolute and differential vacuum values correlate to the presence of leaks and defects within the pouch.If the differential pressure loss is higher than the reference pressure, the pouch fails.During production, leak detection testing is performed on pouches to an aql of 1.5.The sealed pouches are taken directly from the line.The ppm leak defect rate is a calculation of the number of leaks in relation to the number of the pti samples tested and historically is around the value of 2000 ppm (lower than the release specification of aql 1.5).At time of release each batch is evaluated for number of pti tests completed and number of pti tested failed to ensure the release criteria of aql 1.5 is met.Any batch not meeting the release criteria will not be released and will be investigated accordingly following site procedures.Root cause of open pouches is equipment; specifically ultrasonic seal technology is not as forgiving in relation to the foil material as heat seal technology (external machine factors such as process variability and film material variability (wavy, wrinkles, thickness, surlyn conditions, etc.) affect the ability to keep the required film/product alignment and even pressure of the anvils across the sealing areas thus, compromising sealing integrity).In general, the leak defect rate has remained unchanged despite several reliability and engineering initiatives to improve the sealing performance.Heat seal technology offers a more "forgiving" process to accommodate some of these variations and still achieve a hermetic seal, critical to the functionality and longevity of the thermacare product.Capa: the (site name) will purchase and install three (3) new heat seal flow wrapper machines for b and m production lines.The existing bosch flow wrapper equipment used today employs ultrasonic sealing technology for both, the long and cross seals of the thermacare pouches.This technology has proven to be unreliable, difficult to maintain and not flexible enough to accommodate for material variances.The highest consumer complaint for the site is related to pouch sealing defects and the product never worked due to an open pouch.These complaints are directly related to failures during the sealing process.The new machines will utilize heat seal in the cross direction of the film/pouch to achieve a more consistent hermetic seal through the manufacturing runs with the added benefits of easier set up and operation, capa.Complaint handling for open pouches: complaints received at the site in the global complaint database related to open pouch in the subclasses of (but not limited to) never worked, squeeze tube, did not last long enough and too cool will not be investigated in qts.These complaints will be evaluated in the global complaint database to ensure they are due to open pouch and the pouch sealing defect.No additional investigation will be required for these complaints based on the following: released batches meet criteria for pouch leaks at time of release.The severity of pouch leaks is s1, no harm to customer.Complaints related to pouch seal have been thoroughly investigated and root cause is well understood.Leak rate for the current technology is about 2000 ppm.Capa is in-place to replace the ultrasonic sealers with heat seal technology.This document will be attached to the complaint record in the global database and closed with no further action taken.The root cause for never worked, too cool, did not last long enough and squeeze tube complaint sub classless is due to a pouch (primary packaging) that did not seal completely (open pouch).An open pouch will expose the wrap to air before the consumer gets it, causing it to be spent and not heating up.An open pouch is caused by equipment; specifically ultrasonic technology.The corrective action is to purchase and install three (3) new heat seal flow wrapper machines in both production lines.The severity of pouch leaks is s1 no harm to customer.Follow up (05apr2016): new information received from a contactable consumer included the product complaint verbatim "the adhesive layer either comes off too easily or sticks to tightly and pulls the skin (especially neck area)." follow-up (14jun2016): new information received from a contactable consumer included reaction data (additional event of removed some skin/skin abrasion) and the product complaint verbatim the strip did not heat.Follow-up (14jun2016): this follow-up report is being submitted to upgrade this case to a reportable mdr.Follow-up (16nov2019): new information received from a product quality complaint includes: event detail "adheres to tightly and literally removed some skin, never heats up properly", severity of harm, investigation findings, and evaluation of related complaints.Amendment: this follow-up report is being submitted to amend previously reported information: this case has been considered a reportable malfunction.Evaluation codes were also updated.Follow-up (13dec2019): new information received from a product quality complaint group included: site sample status, additional class/subclass, and no impact on regulatory, product quality, and market/clinical and stability.Company clinical evaluation comment: based on the information provided, the events skin abrasion and device adhesion issue as described is considered serious bodily injury potentially requiring medical intervention to prevent permanent damage or impairment of body structure.Event device use issue is non-serious.The events are medically assessed as associated with the use of the device.Company conducted an investigation, the most probable root cause for this event was classified (equipment: open pouches).The severity of pouch leaks is s1, no harm to customer.Capa was implemented, and no further action is recommended., comment: based on the information provided, the events skin abrasion and device adhesion issue as described is considered serious bodily injury potentially requiring medical intervention to prevent permanent damage or impairment of body structure.Event device use issue is non-serious.The events are medically assessed as associated with the use of the device.Company conducted an investigation, the most probable root cause for this event was classified (equipment: open pouches).The severity of pouch leaks is s1, no harm to customer.Capa was implemented, and no further action is recommended.
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Manufacturer Narrative
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Sterile product: no.Samples available: unknown.Rsnbly suggest device malfunc: yes.Severity of harm: s1.Repeat investigation: no.Was capa previously identif'd: yes.Capas in place: no.Full investigation required: no.Process related: no.Final confirmation status: not confirmed.Root cause category (tier 1): equipment.Rsrv.Sample evaluation reqd: no.Lot-specific trend identified: no.Site sample status: not received.Evaluation of complaints related to open pouches (never worked, squeeze tube did not last long enough and too cool): introduction: thermacare heat wraps are premium topical heat therapy products.They function by producing a long lasting therapeutic heat through the controlled oxidation of iron.Primary packaging sealing stops the oxidation process until the consumer opens the wrapped product.The heat wraps are worn against the body or over a layer of clothing to relieve minor muscular and joint aches and pains.The (site name) is the sole manufacturing location for thermacare heat wraps.They are produced on two manufacturing lines; the b line produces the larger products which wrap around the body with stretch materials, and the m line produces the smaller products that are attached for use with pressure sensitive adhesives.The purpose of this document is to summarize customer complaint investigations where the pouch seal (primary packaging) of a thermacare wrap does not seal properly.When the pouch seal is not integral oxygen will enter the pouch and allow the iron oxidation reaction to proceed through completion.Once the reaction is complete the wrap will no longer produce heat.When the wrap is opened by a customer for use no heat will be generated.Consumer complaints of this type come back for evaluation in the subclasses of never worked, did not last long enough, squeeze tube - open pouch, and too cool.This document will summarize this well-known defect, root cause, identified action items and a process to evaluate incoming complai.
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Event Description
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It literally removed some skin/skin abrasion [skin abrasion] , the adhesive adheres too tightly [device adhesion issue] , she uses the wraps to control pain for her cervical and lumbar areas [device use issue].Case narrative: this is a spontaneous report from a contactable consumer.A female patient of an unspecified age started to use thermacare heatwrap (thermacare neck, shoulder & wrist) from an unspecified date to control pain for her cervical and lumbar areas.The patient's medical history and concomitant medications were not reported.It was reported the suspect "products did work but the adhesive layer either comes off too easily or sticks too tightly/adheres to tightly and pulls the skin (especially neck area).During one instance it literally removed some skin on an unspecified date.In some instances it hardly holds at all.A second issue which had only happened once was the strip did not heat, never heats up properly".Also reported, "the product should not cause skin abrasion especially if your research".No hospitalization was needed for the events.Action taken with the suspect product was unknown.Clinical outcome of the events was unknown.On 16nov2019, the following investigation findings was provided from product quality complaint: sterile product: no.Samples available: unknown.Rsnbly suggest device malfunc: yes.Severity of harm: s1.Repeat investigation: no.Was capa previously identif'd: yes.Capas in place: no.Full investigation required: no.Process related: no.Final confirmation status: not confirmed.Root cause category (tier 1): equipment.Rsrv.Sample evaluation reqd: no.Lot-specific trend identified: no.Site sample status: not received.Evaluation of complaints related to open pouches (never worked, squeeze tube did not last long enough and too cool): introduction: thermacare heat wraps are premium topical heat therapy products.They function by producing a long lasting therapeutic heat through the controlled oxidation of iron.Primary packaging sealing stops the oxidation process until the consumer opens the wrapped product.The heat wraps are worn against the body or over a layer of clothing to relieve minor muscular and joint aches and pains.The (site name) is the sole manufacturing location for thermacare heat wraps.They are produced on two manufacturing lines; the b line produces the larger products which wrap around the body with stretch materials, and the m line produces the smaller products that are attached for use with pressure sensitive adhesives.The purpose of this document is to summarize customer complaint investigations where the pouch seal (primary packaging) of a thermacare wrap does not seal properly.When the pouch seal is not integral oxygen will enter the pouch and allow the iron oxidation reaction to proceed through completion.Once the reaction is complete the wrap will no longer produce heat.When the wrap is opened by a customer for use no heat will be generated.Consumer complaints of this type come back for evaluation in the subclasses of never worked, did not last long enough, squeeze tube - open pouch, and too cool.This document will summarize this well-known defect, root cause, identified action items and a process to evaluate incoming complaints of this nature in order to determine the degree and provide justification when no investigation is needed.Severity of this defect aligns with s1: inconvenient, annoying but no harm.Pouch sealing investigations and root cause: in 2013 a complaint trend was opened for the pouch seal defect (major aql of 1.5).The trend directly correlates with the implementation of ultrasonic heat seal technology (replace heat seal technology).Since 2013 complaints for this defect have continued to increase at the site.Complaint investigations for pouch sealing are well characterized due to the number of investigations completed over the years.Pti (pack technology and inspection) is the name of the equipment used to determine the presence of leaks in thermacare heat wrap pouches.Pouches are placed in a test chamber and a known vacuum is applied.The resulting pressure loss is compared to a reference pressure.The changes in absolute and differential vacuum values correlate to the presence of leaks and defects within the pouch.If the differential pressure loss is higher than the reference pressure, the pouch fails.During production, leak detection testing is performed on pouches to an aql of 1.5.The sealed pouches are taken directly from the line.The ppm leak defect rate is a calculation of the number of leaks in relation to the number of the pti samples tested and historically is around the value of 2000 ppm (lower than the release specification of aql 1.5).At time of release each batch is evaluated for number of pti tests completed and number of pti tested failed to ensure the release criteria of aql 1.5 is met.Any batch not meeting the release criteria will not be released and will be investigated accordingly following site procedures.Root cause of open pouches is equipment; specifically ultrasonic seal technology is not as forgiving in relation to the foil material as heat seal technology (external machine factors such as process variability and film material variability (wavy, wrinkles, thickness, surlyn conditions, etc.) affect the ability to keep the required film/product alignment and even pressure of the anvils across the sealing areas thus, compromising sealing integrity).In general, the leak defect rate has remained unchanged despite several reliability and engineering initiatives to improve the sealing performance.Heat seal technology offers a more "forgiving" process to accommodate some of these variations and still achieve a hermetic seal, critical to the functionality and longevity of the thermacare product.Capa: the (site name) will purchase and install three (3) new heat seal flow wrapper machines for b and m production lines.The existing bosch flow wrapper equipment used today employs ultrasonic sealing technology for both, the long and cross seals of the thermacare pouches.This technology has proven to be unreliable, difficult to maintain and not flexible enough to accommodate for material variances.The highest consumer complaint for the site is related to pouch sealing defects and the product never worked due to an open pouch.These complaints are directly related to failures during the sealing process.The new machines will utilize heat seal in the cross direction of the film/pouch to achieve a more consistent hermetic seal through the manufacturing runs with the added benefits of easier set up and operation, capa.Complaint handling for open pouches: complaints received at the site in the global complaint database related to open pouch in the subclasses of (but not limited to) never worked, squeeze tube, did not last long enough and too cool will not be investigated in qts.These complaints will be evaluated in the global complaint database to ensure they are due to open pouch and the pouch sealing defect.No additional investigation will be required for these complaints based on the following: released batches meet criteria for pouch leaks at time of release.The severity of pouch leaks is s1, no harm to customer.Complaints related to pouch seal have been thoroughly investigated and root cause is well understood.Leak rate for the current technology is about 2000 ppm.Capa is in-place to replace the ultrasonic sealers with heat seal technology.This document will be attached to the complaint record in the global database and closed with no further action taken.The root cause for never worked, too cool, did not last long enough and squeeze tube complaint sub classless is due to a pouch (primary packaging) that did not seal completely (open pouch).An open pouch will expose the wrap to air before the consumer gets it, causing it to be spent and not heating up.An open pouch is caused by equipment; specifically ultrasonic technology.The corrective action is to purchase and install three (3) new heat seal flow wrapper machines in both production lines.The severity of pouch leaks is s1 no harm to customer.Follow up (05apr2016): new information received from a contactable consumer included the product complaint verbatim "the adhesive layer either comes off too easily or sticks to tightly and pulls the skin (especially neck area)." follow-up (14jun2016): new information received from a contactable consumer included reaction data (additional event of removed some skin/skin abrasion) and the product complaint verbatim the strip did not heat.Follow-up (14jun2016): this follow-up report is being submitted to upgrade this case to a reportable mdr.Follow-up (16nov2019): new information received from a product quality complaint includes: event detail "adheres to tightly and literally removed some skin, never heats up properly", severity of harm, investigation findings, and evaluation of related complaints.Amendment: this follow-up report is being submitted to amend previously reported information: this case has been considered a reportable malfunction.Evaluation codes were also updated.Company clinical evaluation comment: based on the information provided, the events skin abrasion and device adhesion issue as described is considered serious bodily injury potentially requiring medical intervention to prevent permanent damage or impairment of body structure.Event device use issue is non-serious.The events are medically assessed as associated with the use of the device.Company conducted an investigation, the most probable root cause for this event was classified (equipment: open pouches).The severity of pouch leaks is s1, no harm to customer.Capa was implemented, and no further action is recommended.Comment: based on the information provided, the events skin abrasion and device adhesion issue as described is considered serious bodily injury potentially requiring medical intervention to prevent permanent damage or impairment of body structure.Event device use issue is non-serious.The events are medically assessed as associated with the use of the device.Company conducted an investigation, the most probable root cause for this event was classified (equipment: open pouches).The severity of pouch leaks is s1, no harm to customer.Capa was implemented, and no further action is recommended.
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Event Description
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Event verbatim [preferred term] it literally removed some skin/skin abrasion [skin abrasion] , the adhesive adheres too tightly [device adhesion issue] , she uses the wraps to control pain for her cervical and lumbar areas [device use issue] ,.Case narrative:this is a spontaneous report from a contactable consumer.A female patient of an unspecified age started to use thermacare heatwrap (thermacare neck, shoulder & wrist) from an unspecified date to control pain for her cervical and lumbar areas.The patient's medical history and concomitant medications were not reported.It was reported the suspect "products did work but the adhesive layer either comes off too easily or sticks too tightly/adheres to tightly and pulls the skin (especially neck area).During one instance it literally removed some skin on an unspecified date.In some instances it hardly holds at all.A second issue which had only happened once was the strip did not heat, never heats up properly".Also reported, "the product should not cause skin abrasion especially if your research".No hospitalization was needed for the events.Action taken with the suspect product was unknown.Clinical outcome of the events was unknown.Following investigation findings was provided from product quality complaint: sterile product: no.Samples available: unknown.Rsnbly suggest device malfunc: yes.Severity of harm: s1.Repeat investigation: no.Was capa previously identif'd: yes.Capas in place: no.Full investigation required: no.Process related: no.Final confirmation status: not confirmed.Root cause category (tier 1): equipment.Rsrv.Sample evaluation reqd: no.Lot-specific trend identified: no.Site sample status: not received.Evaluation of complaints related to open pouches (never worked, squeeze tube did not last long enough and too cool): introduction: thermacare heat wraps are premium topical heat therapy products.They function by producing a long lasting therapeutic heat through the controlled oxidation of iron.Primary packaging sealing stops the oxidation process until the consumer opens the wrapped product.The heat wraps are worn against the body or over a layer of clothing to relieve minor muscular and joint aches and pains.The (site name) is the sole manufacturing location for thermacare heat wraps.They are produced on two manufacturing lines; the b line produces the larger products which wrap around the body with stretch materials, and the m line produces the smaller products that are attached for use with pressure sensitive adhesives.The purpose of this document is to summarize customer complaint investigations where the pouch seal (primary packaging) of a thermacare wrap does not seal properly.When the pouch seal is not integral oxygen will enter the pouch and allow the iron oxidation reaction to proceed through completion.Once the reaction is complete the wrap will no longer produce heat.When the wrap is opened by a customer for use no heat will be generated.Consumer complaints of this type come back for evaluation in the subclasses of never worked, did not last long enough, squeeze tube - open pouch, and too cool.This document will summarize this well-known defect, root cause, identified action items and a process to evaluate incoming complaints of this nature in order to determine the degree and provide justification when no investigation is needed.Severity of this defect aligns with s1: inconvenient, annoying but no harm.Pouch sealing investigations and root cause: in 2013 a complaint trend was opened for the pouch seal defect (major aql of 1.5).The trend directly correlates with the implementation of ultrasonic heat seal technology (replace heat seal technology).Since 2013 complaints for this defect have continued to increase at the site.Complaint investigations for pouch sealing are well characterized due to the number of investigations completed over the years.Pti (pack technology and inspection) is the name of the equipment used to determine the presence of leaks in thermacare heat wrap pouches.Pouches are placed in a test chamber and a known vacuum is applied.The resulting pressure loss is compared to a reference pressure.The changes in absolute and differential vacuum values correlate to the presence of leaks and defects within the pouch.If the differential pressure loss is higher than the reference pressure, the pouch fails.During production, leak detection testing is performed on pouches to an aql of 1.5.The sealed pouches are taken directly from the line.The ppm leak defect rate is a calculation of the number of leaks in relation to the number of the pti samples tested and historically is around the value of 2000 ppm (lower than the release specification of aql 1.5).At time of release each batch is evaluated for number of pti tests completed and number of pti tested failed to ensure the release criteria of aql 1.5 is met.Any batch not meeting the release criteria will not be released and will be investigated accordingly following site procedures.Root cause of open pouches is equipment; specifically ultrasonic seal technology is not as forgiving in relation to the foil material as heat seal technology (external machine factors such as process variability and film material variability (wavy, wrinkles, thickness, surlyn conditions, etc.) affect the ability to keep the required film/product alignment and even pressure of the anvils across the sealing areas thus, compromising sealing integrity).In general, the leak defect rate has remained unchanged despite several reliability and engineering initiatives to improve the sealing performance.Heat seal technology offers a more "forgiving" process to accommodate some of these variations and still achieve a hermetic seal, critical to the functionality and longevity of the thermacare product.Capa: the (site name) will purchase and install three (3) new heat seal flow wrapper machines for b and m production lines.The existing bosch flow wrapper equipment used today employs ultrasonic sealing technology for both, the long and cross seals of the thermacare pouches.This technology has proven to be unreliable, difficult to maintain and not flexible enough to accommodate for material variances.The highest consumer complaint for the site is related to pouch sealing defects and the product never worked due to an open pouch.These complaints are directly related to failures during the sealing process.The new machines will utilize heat seal in the cross direction of the film/pouch to achieve a more consistent hermetic seal through the manufacturing runs with the added benefits of easier set up and operation, capa.Complaint handling for open pouches: complaints received at the site in the global complaint database related to open pouch in the subclasses of (but not limited to) never worked, squeeze tube, did not last long enough and too cool will not be investigated in qts.These complaints will be evaluated in the global complaint database to ensure they are due to open pouch and the pouch sealing defect.No additional investigation will be required for these complaints based on the following: released batches meet criteria for pouch leaks at time of release.The severity of pouch leaks is s1, no harm to customer.Complaints related to pouch seal have been thoroughly investigated and root cause is well understood.Leak rate for the current technology is about 2000 ppm.Capa is in-place to replace the ultrasonic sealers with heat seal technology.This document will be attached to the complaint record in the global database and closed with no further action taken.The root cause for never worked, too cool, did not last long enough and squeeze tube complaint sub classless is due to a pouch (primary packaging) that did not seal completely (open pouch).An open pouch will expose the wrap to air before the consumer gets it, causing it to be spent and not heating up.An open pouch is caused by equipment; specifically ultrasonic technology.The corrective action is to purchase and install three (3) new heat seal flow wrapper machines in both production lines.The severity of pouch leaks is s1 no harm to customer.Follow up (05apr2016): new information received from a contactable consumer included the product complaint verbatim "the adhesive layer either comes off too easily or sticks to tightly and pulls the skin (especially neck area)." follow-up (14jun2016): new information received from a contactable consumer included reaction data (additional event of removed some skin/skin abrasion) and the product complaint verbatim the strip did not heat.Follow-up (14jun2016): this follow-up report is being submitted to upgrade this case to a reportable mdr.Follow-up (16nov2019): new information received from a product quality complaint includes: event detail "adheres to tightly and literally removed some skin, never heats up properly", severity of harm, investigation findings, and evaluation of related complaints.Company clinical evaluation comment: based on the information provided, the events skin abrasion and device adhesion issue as described is considered serious bodily injury potentially requiring medical intervention to prevent permanent damage or impairment of body structure.Event device use issue is non-serious.The events are medically assessed as associated with the use of the device.Company conducted an investigation, the most probable root cause for this event was classified (equipment: open pouches).The severity of pouch leaks is s1, no harm to customer.Capa was implemented, and no further action is recommended., comment: based on the information provided, the events skin abrasion and device adhesion issue as described is considered serious bodily injury potentially requiring medical intervention to prevent permanent damage or impairment of body structure.Event device use issue is non-serious.The events are medically assessed as associated with the use of the device.Company conducted an investigation, the most probable root cause for this event was classified (equipment: open pouches).The severity of pouch leaks is s1, no harm to customer.Capa was implemented, and no further action is recommended.
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Manufacturer Narrative
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Sterile product: no.Samples available: unknown.Rsnbly suggest device malfunc: yes.Severity of harm: s1.Repeat investigation: no.Was capa previously identif'd: yes.Capas in place: no.Full investigation required: no.Process related: no.Final confirmation status: not confirmed.Root cause category (tier 1): equipment.Rsrv.Sample evaluation reqd: no.Lot-specific trend identified: no.Site sample status: not received.Evaluation of complaints related to open pouches (never worked, squeeze tube did not last long enough and too cool): introduction: thermacare heat wraps are premium topical heat therapy products.They function by producing a long lasting therapeutic heat through the controlled oxidation of iron.Primary packaging sealing stops the oxidation process until the consumer opens the wrapped product.The heat wraps are worn against the body or over a layer of clothing to relieve minor muscular and joint aches and pains.The (site name) is the sole manufacturing location for thermacare heat wraps.They are produced on two manufacturing lines; the b line produces the larger products which wrap around the body with stretch materials, and the m line produces the smaller products that are attached for use with pressure sensitive adhesives.The purpose of this document is to summarize customer complaint investigations where the pouch seal (primary packaging) of a thermacare wrap does not seal properly.When the pouch seal is not integral oxygen will enter the pouch and allow the iron oxidation reaction to proceed through completion.Once the reaction is complete the wrap will no longer produce heat.When the wrap is opened by a customer for use no heat will be generated.Consumer complaints of this type come back for evaluation in the subclasses of never worked, did not last long enough, squeeze tube - open pouch, and too cool.This document will summarize this well-known defect, root cause, identified action items and a process to evaluate incoming complai.
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Event Description
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Event verbatim [preferred term] it literally removed some skin/skin abrasion [skin abrasion] , the adhesive adheres too tightly [device adhesion issue] , she uses the wraps to control pain for her cervical and lumbar areas [device use issue] ,.Case narrative:this is a spontaneous report from a contactable consumer.A female patient of an unspecified age started to use thermacare heatwrap (thermacare neck, shoulder & wrist) from an unspecified date to control pain for her cervical and lumbar areas.The patient's medical history and concomitant medications were not reported.It was reported "the suspect products did work but the adhesive layer either comes off too easily or sticks too tightly/adheres to tightly and pulls the skin (especially neck area).During one instance it literally removed some skin on an unspecified date.In some instances it hardly holds at all.A second issue which had only happened once was the strip did not heat, never heats up properly".Also reported, "the product should not cause skin abrasion especially if your research".No hospitalization was needed for the events.Action taken with the suspect product was unknown.Clinical outcome of the events was unknown.On (b)(6) 2019, the following investigation findings was provided from product quality complaint: sterile product: no.Samples available: unknown.Reasonably suggest device malfunction: yes.Severity of harm: s1.Class: product use attributes.Sub class: wrap/patch/pad never worked/unusable/cannot be reused.Class: external cause investigation.Sub class: adverse event safety request for investigation.Was capa previously identified: yes.Capas in place: no.Process related: no.Final confirmation status: not confirmed.Root cause category (tier 1): equipment.Reserve sample evaluation and testing required.N.Lot-specific trend and expedited trend identified: no.Lot trend assessment & rationale: refer to evaluation of complaints related to open pouches.Sample status: not requested.Site sample status: not received.There was no impact on regulatory, product quality, and market/clinical and stability.Evaluation of complaints related to open pouches (never worked, squeeze tube did not last long enough and too cool): introduction: thermacare heat wraps are premium topical heat therapy products.They function by producing a long lasting therapeutic heat through the controlled oxidation of iron.Primary packaging sealing stops the oxidation process until the consumer opens the wrapped product.The heat wraps are worn against the body or over a layer of clothing to relieve minor muscular and joint aches and pains.The (site name) is the sole manufacturing location for thermacare heat wraps.They are produced on two manufacturing lines; the b line produces the larger products which wrap around the body with stretch materials, and the m line produces the smaller products that are attached for use with pressure sensitive adhesives.The purpose of this document is to summarize customer complaint investigations where the pouch seal (primary packaging) of a thermacare wrap does not seal properly.When the pouch seal is not integral oxygen will enter the pouch and allow the iron oxidation reaction to proceed through completion.Once the reaction is complete the wrap will no longer produce heat.When the wrap is opened by a customer for use no heat will be generated.Consumer complaints of this type come back for evaluation in the subclasses of never worked, did not last long enough, squeeze tube - open pouch, and too cool.This document will summarize this well-known defect, root cause, identified action items and a process to evaluate incoming complaints of this nature in order to determine the degree and provide justification when no investigation is needed.Severity of this defect aligns with s1: inconvenient, annoying but no harm.Pouch sealing investigations and root cause: in 2013 a complaint trend was opened for the pouch seal defect (major aql of 1.5).The trend directly correlates with the implementation of ultrasonic heat seal technology (replace heat seal technology).Since 2013 complaints for this defect have continued to increase at the site.Complaint investigations for pouch sealing are well characterized due to the number of investigations completed over the years.Pack technology and inspection is the name of the equipment used to determine the presence of leaks in thermacare heat wrap pouches.Pouches are placed in a test chamber and a known vacuum is applied.The resulting pressure loss is compared to a reference pressure.The changes in absolute and differential vacuum values correlate to the presence of leaks and defects within the pouch.If the differential pressure loss is higher than the reference pressure, the pouch fails.During production, leak detection testing is performed on pouches to an aql of 1.5.The sealed pouches are taken directly from the line.The ppm leak defect rate is a calculation of the number of leaks in relation to the number of the pti samples tested and historically is around the value of 2000 ppm (lower than the release specification of aql 1.5).At time of release each batch is evaluated for number of pti tests completed and number of pti tested failed to ensure the release criteria of aql 1.5 is met.Any batch not meeting the release criteria will not be released and will be investigated accordingly following site procedures.Root cause of open pouches is equipment; specifically ultrasonic seal technology is not as forgiving in relation to the foil material as heat seal technology (external machine factors such as process variability and film material variability (wavy, wrinkles, thickness, surlyn conditions, etc.) affect the ability to keep the required film/product alignment and even pressure of the anvils across the sealing areas thus, compromising sealing integrity).In general, the leak defect rate has remained unchanged despite several reliability and engineering initiatives to improve the sealing performance.Heat seal technology offers a more "forgiving" process to accommodate some of these variations and still achieve a hermetic seal, critical to the functionality and longevity of the thermacare product.Capa: the (site name) will purchase and install three (3) new heat seal flow wrapper machines for b and m production lines.The existing bosch flow wrapper equipment used today employs ultrasonic sealing technology for both, the long and cross seals of the thermacare pouches.This technology has proven to be unreliable, difficult to maintain and not flexible enough to accommodate for material variances.The highest consumer complaint for the site is related to pouch sealing defects and the product never worked due to an open pouch.These complaints are directly related to failures during the sealing process.The new machines will utilize heat seal in the cross direction of the film/pouch to achieve a more consistent hermetic seal through the manufacturing runs with the added benefits of easier set up and operation, capa.Complaint handling for open pouches: complaints received at the site in the global complaint database related to open pouch in the subclasses of (but not limited to) never worked, squeeze tube, did not last long enough and too cool will not be investigated in qts.These complaints will be evaluated in the global complaint database to ensure they are due to open pouch and the pouch sealing defect.No additional investigation will be required for these complaints based on the following: released batches meet criteria for pouch leaks at time of release.The severity of pouch leaks is s1, no harm to customer.Complaints related to pouch seal have been thoroughly investigated and root cause is well understood.Leak rate for the current technology is about 2000 ppm.Capa is in-place to replace the ultrasonic sealers with heat seal technology.This document will be attached to the complaint record in the global database and closed with no further action taken.The root cause for never worked, too cool, did not last long enough and squeeze tube complaint sub classless is due to a pouch (primary packaging) that did not seal completely (open pouch).An open pouch will expose the wrap to air before the consumer gets it, causing it to be spent and not heating up.An open pouch is caused by equipment; specifically ultrasonic technology.The corrective action is to purchase and install three (3) new heat seal flow wrapper machines in both production lines.The severity of pouch leaks is s1 no harm to customer.Summary of investigation: this investigation was conducted for an unknown lot number neck/shoulder/wrist (nsw) 8 hour product.There was limited device specific information provided, no batch number or return sample was available for evaluation.Without a batch reference number and /or return sample a manufacturing and technical evaluation cannot be completed for the wrap involved in this case.There is not a trend identified related for the subclass adhesion/fastening defect.Conclusion: the root cause category is non-assignable (complaint not confirmed as a quality defect).There was limited device specific information provided, no batch number or return sample was available for evaluation.Without a batch reference number and/or return sample a manufacturing and technical evaluation cannot be completed for the wrap involved in this case.There is not a product quality related trend identified for the subclass adhesion/fastening defect.The manufacturing operations employ quality control procedures which include in process testing, thermal testing and visual inspection, to ensure the quality of the product being packaged.Lot trend assmt.& rationale: a lot trend was not performed as the lot number is unknown.The sample had not been received by the site.Follow up ((b)(6) 2016): new information received from a contactable consumer included the product complaint verbatim "the adhesive layer either comes off too easily or sticks to tightly and pulls the skin (especially neck area)." follow-up ((b)(6) 2016): new information received from a contactable consumer included reaction data (additional event of removed some skin/skin abrasion) and the product complaint verbatim the strip did not heat.Follow-up ((b)(6) 2016): this follow-up report is being submitted to upgrade this case to a reportable mdr.Follow-up ((b)(6) 2019): new information received from a product quality complaint includes: event detail "adheres to tightly and literally removed some skin, never heats up properly", severity of harm, investigation findings, and evaluation of related complaints.Amendment: this follow-up report is being submitted to amend previously reported information: this case has been considered a reportable malfunction.Evaluation codes were also updated.Follow-up ((b)(6) 2019): new information received from a product quality complaint group included: site sample status, additional class/subclass, and no impact on regulatory, product quality, and market/clinical and stability.Follow-up ((b)(6) 2020): new information received from a product quality complaint group included: investigation results.Company clinical evaluation comment: based on the information provided, the events skin abrasion and device adhesion issue as described is considered serious bodily injury potentially requiring medical intervention to prevent permanent damage or impairment of body structure.Event device use issue is non-serious.The events are medically assessed as associated with the use of the device.Company conducted an investigation, the most probable root cause for this event was classified (equipment: open pouches).The severity of pouch leaks is s1, no harm to customer.Capa was implemented, and no further action is recommended., comment: based on the information provided, the events skin abrasion and device adhesion issue as described is considered serious bodily injury potentially requiring medical intervention to prevent permanent damage or impairment of body structure.Event device use issue is non-serious.The events are medically assessed as associated with the use of the device.Company conducted an investigation, the most probable root cause for this event was classified (equipment: open pouches).The severity of pouch leaks is s1, no harm to customer.Capa was implemented, and no further action is recommended.
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Manufacturer Narrative
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Sterile product: no.Samples available: unknown.Reasonably suggest device malfunction: yes.Severity of harm: s1.Class: product use attributes.Sub class: wrap/patch/pad never worked/unusable/cannot be reused.Class: external cause investigation.Sub class: adverse event safety request for investigation.Was capa previously identified: yes.Capas in place: no.Process related: no.Final confirmation status: not confirmed.Root cause category (tier 1): equipment.Reserve sample evaluation and testing required.N.Lot-specific trend and expedited trend identified: no.Lot trend assessment & rationale: refer to evaluation of complaints related to open pouches.Sample status: not requested.Site sample status: not received.There was no impact on regulatory, product quality, and market/clinical and stability.Evaluation of complaints related to open pouches (never worked, squeeze tube did not last long enough and too cool): introduction: thermacare heat wraps are premium topical heat therapy products.They function by producing a long lasting therapeutic heat through the controlled oxidation of iron.Primary packaging sealing stops the oxidation process until the consumer opens the wrapped product.The heat wraps are worn against the body or over a layer of clothing to relieve minor muscular and joint aches and pains.The (site name) is the sole manufacturing location for thermacare heat wraps.They are produced on two manufacturing lines; the b line produces the larger products which wrap around the body with stretch materials, and the m line produces the smaller products that are attached for use with pressure sensitive adhesives.The purpose of this document is to summarize customer complaint investigations where the pouch seal (primary packaging) of a thermacare wrap does not seal properly.When the pouch seal is not integral oxygen will enter the pouch and allow the iron oxidation reaction to proceed through completion.Once the reaction is complete the wrap will.
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Manufacturer Narrative
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Sterile product: no.Samples available: unknown.Reasonably suggest device malfunction: yes.Severity of harm: s1.Class: product use attributes.Sub class: wrap/patch/pad never worked/unusable/cannot be reused.Class: external cause investigation.Sub class: adverse event safety request for investigation.Was capa previously identified: yes.Capas in place: no.Process related: no.Final confirmation status: not confirmed.Root cause category (tier 1): equipment.Reserve sample evaluation and testing required.N.Lot-specific trend and expedited trend identified: no.Lot trend assessment & rationale: refer to evaluation of complaints related to open pouches.Sample status: not requested.Site sample status: not received.There was no impact on regulatory, product quality, and market/clinical and stability.Evaluation of complaints related to open pouches (never worked, squeeze tube did not last long enough and too cool): introduction: thermacare heat wraps are premium topical heat therapy products.They function by producing a long lasting therapeutic heat through the controlled oxidation of iron.Primary packaging sealing stops the oxidation process until the consumer opens the wrapped product.The heat wraps are worn against the body or over a layer of clothing to relieve minor muscular and joint aches and pains.The (site name) is the sole manufacturing location for thermacare heat wraps.They are produced on two manufacturing lines; the b line produces the larger products which wrap around the body with stretch materials, and the m line produces the smaller products that are attached for use with pressure sensitive adhesives.The purpose of this document is to summarize customer complaint investigations where the pouch seal (primary packaging) of a thermacare wrap does not seal properly.When the pouch seal is not integral oxygen will enter the pouch and allow the iron oxidation reaction to proceed through completion.Once the reaction is complete the wrap will no longer produce heat.When the wrap is opened by a customer for use no heat will be generated.Consumer complaints of this type come back for evaluation in the subclasses of never worked, did not last long enough, squeeze tube - open pouch, and too cool.This document will summarize this well-known defect, root cause, identified action items and a process to evaluate incoming complaints of this nature in order to determine the degree and provide justification when no investigation is needed.Severity of this defect aligns with s1: inconvenient, annoying but no harm.Pouch sealing investigations and root cause: in 2013 a complaint trend was opened for the pouch seal defect (major aql of 1.5).The trend directly correlates with the implementation of ultrasonic heat seal technology (replace heat seal technology).Since 2013 complaints for this defect have continued to increase at the site.Complaint investigations for pouch sealing are well characterized due to the number of investigations completed over the years.Pack technology and inspection is the name of the equipment used to determine the presence of leaks in thermacare heat wrap pouches.Pouches are placed in a test chamber and a known vacuum is applied.The resulting pressure loss is compared to a reference pressure.The changes in absolute and differential vacuum values correlate to the presence of leaks and defects within the pouch.If the differential pressure loss is higher than the reference pressure, the pouch fails.During production, leak detection testing is performed on pouches to an aql of 1.5.The sealed pouches are taken directly from the line.The ppm leak defect rate is a calculation of the number of leaks in relation to the number of the pti samples tested and historically is around the value of 2000 ppm (lower than the release specification of aql 1.5).At time of release each batch is evaluated for number of pti tests completed and number of pti tested failed to ensure the release criteria of aql 1.5 is met.Any batch not meeting the release criteria will not be released and will be investigated accordingly following site procedures.Root cause of open pouches is equipment; specifically ultrasonic seal technology is not as forgiving in relation to the foil material as heat seal technology (external machine factors such as process variability and film material variability (wavy, wrinkles, thickness, surlyn conditions, etc.) affect the ability to keep the required film/product alignment and even pressure of the anvils across the sealing areas thus, compromising sealing integrity).In general, the leak defect rate has remained unchanged despite several reliability and engineering initiatives to improve the sealing performance.Heat seal technology offers a more "forgiving" process to accommodate some of these variations and still achieve a hermetic seal, critical to the functionality and longevity of the thermacare product.Capa: the (site name) will purchase and install three (3) new heat seal flow wrapper machines for b and m production lines.The existing bosch flow wrapper equipment used today employs ultrasonic sealing technology for both, the long and cross seals of the thermacare pouches.This technology has proven to be unreliable, difficult to maintain and not flexible enough to accommodate for material variances.The highest consumer complaint for the site is related to pouch sealing defects and the product never worked due to an open pouch.These complaints are directly related to failures during the sealing process.The new machines will utilize heat seal in the cross direction of the film/pouch to achieve a more consistent hermetic seal through the manufacturing runs with the added benefits of easier set up and operation, capa.Complaint handling for open pouches: complaints received at the site in the global complaint database related to open pouch in the subclasses of (but not limited to) never worked, squeeze tube, did not last long enough and too cool will not be investigated in qts.These complaints will be evaluated in the global complaint database to ensure they are due to open pouch and the pouch sealing defect.No additional investigation will be required for these complaints based on the following: released batches meet criteria for pouch leaks at time of release.The severity of pouch leaks is s1, no harm to customer.Complaints related to pouch seal have been thoroughly investigated and root cause is well understood.Leak rate for the current technology is about 2000 ppm.Capa is in-place to replace the ultrasonic sealers with heat seal technology.This document will be attached to the complaint record in the global database and closed with no further action taken.The root cause for never worked, too cool, did not last long enough and squeeze tube complaint sub classless is due to a pouch (primary packaging) that did not seal completely (open pouch).An open pouch will expose the wrap to air before the consumer gets it, causing it to be spent and not heating up.An open pouch is caused by equipment; specifically ultrasonic technology.The corrective action is to purchase and install three (3) new heat seal flow wrapper machines in both production lines.The severity of pouch leaks is s1 no harm to customer.Summary of investigation: this investigation was conducted for an unknown lot number neck/shoulder/wrist (nsw) 8 hour product.There was limited device specific information provided, no batch number or return sample was available for evaluation.Without a batch reference number and /or return sample a manufacturing and technical evaluation cannot be completed for the wrap involved in this case.There is not a trend identified related for the subclass adhesion/fastening defect.Conclusion: the root cause category is non-assignable (complaint not confirmed as a quality defect).There was limited device specific information provided, no batch number or return sample was available for evaluation.Without a batch reference number and/or return sample a manufacturing and technical evaluation cannot be completed for the wrap involved in this case.There is not a product quality related trend identified for the subclass adhesion/fastening defect.The manufacturing operations employ quality control procedures which include in process testing, thermal testing and visual inspection, to ensure the quality of the product being packaged.Lot trend assmt.& rationale: a lot trend was not performed as the lot number is unknown.The sample had not been received by the site.On (b)(6) 2020, product quality complaints provided the following investigation results for subclass adverse event safety request for investigation: a sample was not received a the site.This investigation was conducted for an unknown lot number neck/shoulder/wrist (nsw) 8 hour product.There is no device history record (dhr) reviewed for an unknown batch number.A lot trend was not performed as the lot number is unknown.The root cause category is non-assignable (complaint not confirmed as a quality defect).There was limited device specific information provided, no batch number or return sample was available for evaluation.Without a batch reference number and/or return sample a manufacturing and technical evaluation cannot be completed for the wrap involved in this case.There is not a product quality related trend identified for the subclass adverse event safety request for investigation.The manufacturing operations employ quality control procedures which include in process testing, thermal testing and visual inspection, to ensure the quality of the product being packaged.
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Event Description
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Event verbatim [preferred term].It literally removed some skin/skin abrasion [skin abrasion], the adhesive adheres too tightly [device adhesion issue], she uses the wraps to control pain for her cervical and lumbar areas [device use issue].Narrative: this is a spontaneous report from a contactable consumer.A female patient of an unspecified age started to use thermacare heatwrap (thermacare neck, shoulder & wrist) from an unspecified date to control pain for her cervical and lumbar areas.The patient's medical history and concomitant medications were not reported.It was reported "the suspect products did work but the adhesive layer either comes off too easily or sticks too tightly/adheres to tightly and pulls the skin (especially neck area).During one instance it literally removed some skin on an unspecified date.In some instances it hardly holds at all.A second issue which had only happened once was the strip did not heat, never heats up properly".Also reported, "the product should not cause skin abrasion especially if your research".No hospitalization was needed for the events.Action taken with the suspect product was unknown.Clinical outcome of the events was unknown.On (b)(6) 2019, the following investigation findings was provided from product quality complaint: sterile product: no.Samples available: unknown.Reasonably suggest device malfunction: yes.Severity of harm: s1.Class: product use attributes.Sub class: wrap/patch/pad never worked/unusable/cannot be reused.Class: external cause investigation.Sub class: adverse event safety request for investigation.Was capa previously identified: yes.Capas in place: no.Process related: no.Final confirmation status: not confirmed.Root cause category (tier 1): equipment.Reserve sample evaluation and testing required.N.Lot-specific trend and expedited trend identified: no.Lot trend assessment & rationale: refer to evaluation of complaints related to open pouches.Sample status: not requested.Site sample status: not received.There was no impact on regulatory, product quality, and market/clinical and stability.Evaluation of complaints related to open pouches (never worked, squeeze tube did not last long enough and too cool): introduction: thermacare heat wraps are premium topical heat therapy products.They function by producing a long lasting therapeutic heat through the controlled oxidation of iron.Primary packaging sealing stops the oxidation process until the consumer opens the wrapped product.The heat wraps are worn against the body or over a layer of clothing to relieve minor muscular and joint aches and pains.The (site name) is the sole manufacturing location for thermacare heat wraps.They are produced on two manufacturing lines; the b line produces the larger products which wrap around the body with stretch materials, and the m line produces the smaller products that are attached for use with pressure sensitive adhesives.The purpose of this document is to summarize customer complaint investigations where the pouch seal (primary packaging) of a thermacare wrap does not seal properly.When the pouch seal is not integral oxygen will enter the pouch and allow the iron oxidation reaction to proceed through completion.Once the reaction is complete the wrap will no longer produce heat.When the wrap is opened by a customer for use no heat will be generated.Consumer complaints of this type come back for evaluation in the subclasses of never worked, did not last long enough, squeeze tube - open pouch, and too cool.This document will summarize this well-known defect, root cause, identified action items and a process to evaluate incoming complaints of this nature in order to determine the degree and provide justification when no investigation is needed.Severity of this defect aligns with s1: inconvenient, annoying but no harm.Pouch sealing investigations and root cause: in 2013 a complaint trend was opened for the pouch seal defect (major aql of 1.5).The trend directly correlates with the implementation of ultrasonic heat seal technology (replace heat seal technology).Since 2013 complaints for this defect have continued to increase at the site.Complaint investigations for pouch sealing are well characterized due to the number of investigations completed over the years.Pack technology and inspection is the name of the equipment used to determine the presence of leaks in thermacare heat wrap pouches.Pouches are placed in a test chamber and a known vacuum is applied.The resulting pressure loss is compared to a reference pressure.The changes in absolute and differential vacuum values correlate to the presence of leaks and defects within the pouch.If the differential pressure loss is higher than the reference pressure, the pouch fails.During production, leak detection testing is performed on pouches to an aql of 1.5.The sealed pouches are taken directly from the line.The ppm leak defect rate is a calculation of the number of leaks in relation to the number of the pti samples tested and historically is around the value of 2000 ppm (lower than the release specification of aql 1.5).At time of release each batch is evaluated for number of pti tests completed and number of pti tested failed to ensure the release criteria of aql 1.5 is met.Any batch not meeting the release criteria will not be released and will be investigated accordingly following site procedures.Root cause of open pouches is equipment; specifically ultrasonic seal technology is not as forgiving in relation to the foil material as heat seal technology (external machine factors such as process variability and film material variability (wavy, wrinkles, thickness, surlyn conditions, etc.) affect the ability to keep the required film/product alignment and even pressure of the anvils across the sealing areas thus, compromising sealing integrity).In general, the leak defect rate has remained unchanged despite several reliability and engineering initiatives to improve the sealing performance.Heat seal technology offers a more "forgiving" process to accommodate some of these variations and still achieve a hermetic seal, critical to the functionality and longevity of the thermacare product.Capa: the (site name) will purchase and install three (3) new heat seal flow wrapper machines for b and m production lines.The existing bosch flow wrapper equipment used today employs ultrasonic sealing technology for both, the long and cross seals of the thermacare pouches.This technology has proven to be unreliable, difficult to maintain and not flexible enough to accommodate for material variances.The highest consumer complaint for the site is related to pouch sealing defects and the product never worked due to an open pouch.These complaints are directly related to failures during the sealing process.The new machines will utilize heat seal in the cross direction of the film/pouch to achieve a more consistent hermetic seal through the manufacturing runs with the added benefits of easier set up and operation, capa.Complaint handling for open pouches: complaints received at the site in the global complaint database related to open pouch in the subclasses of (but not limited to) never worked, squeeze tube, did not last long enough and too cool will not be investigated in qts.These complaints will be evaluated in the global complaint database to ensure they are due to open pouch and the pouch sealing defect.No additional investigation will be required for these complaints based on the following: released batches meet criteria for pouch leaks at time of release.The severity of pouch leaks is s1, no harm to customer.Complaints related to pouch seal have been thoroughly investigated and root cause is well understood.Leak rate for the current technology is about 2000 ppm.Capa is in-place to replace the ultrasonic sealers with heat seal technology.This document will be attached to the complaint record in the global database and closed with no further action taken.The root cause for never worked, too cool, did not last long enough and squeeze tube complaint sub classless is due to a pouch (primary packaging) that did not seal completely (open pouch).An open pouch will expose the wrap to air before the consumer gets it, causing it to be spent and not heating up.An open pouch is caused by equipment; specifically ultrasonic technology.The corrective action is to purchase and install three (3) new heat seal flow wrapper machines in both production lines.The severity of pouch leaks is s1 no harm to customer.Summary of investigation: this investigation was conducted for an unknown lot number neck/shoulder/wrist (nsw) 8 hour product.There was limited device specific information provided, no batch number or return sample was available for evaluation.Without a batch reference number and /or return sample a manufacturing and technical evaluation cannot be completed for the wrap involved in this case.There is not a trend identified related for the subclass adhesion/fastening defect.Conclusion: the root cause category is non-assignable (complaint not confirmed as a quality defect).There was limited device specific information provided, no batch number or return sample was available for evaluation.Without a batch reference number and/or return sample a manufacturing and technical evaluation cannot be completed for the wrap involved in this case.There is not a product quality related trend identified for the subclass adhesion/fastening defect.The manufacturing operations employ quality control procedures which include in process testing, thermal testing and visual inspection, to ensure the quality of the product being packaged.Lot trend assmt.& rationale: a lot trend was not performed as the lot number is unknown.The sample had not been received by the site.On (b)(6) 2020, product quality complaints provided the following investigation results for subclass adverse event safety request for investigation: a sample was not received a the site.This investigation was conducted for an unknown lot number neck/shoulder/wrist (nsw) 8 hour product.There is no device history record (dhr) reviewed for an unknown batch number.A lot trend was not performed as the lot number is unknown.The root cause category is non-assignable (complaint not confirmed as a quality defect).There was limited device specific information provided, no batch number or return sample was available for evaluation.Without a batch reference number and/or return sample a manufacturing and technical evaluation cannot be completed for the wrap involved in this case.There is not a product quality related trend identified for the subclass adverse event safety request for investigation.The manufacturing operations employ quality control procedures which include in process testing, thermal testing and visual inspection, to ensure the quality of the product being packaged follow up (05apr2016): new information received from a contactable consumer included the product complaint verbatim "the adhesive layer either comes off too easily or sticks to tightly and pulls the skin (especially neck area)." follow-up (14jun2016): new information received from a contactable consumer included reaction data (additional event of removed some skin/skin abrasion) and the product complaint verbatim the strip did not heat.Follow-up (14jun2016): this follow-up report is being submitted to upgrade this case to a reportable mdr.Follow-up (16nov2019): new information received from a product quality complaint includes: event detail "adheres to tightly and literally removed some skin, never heats up properly", severity of harm, investigation findings, and evaluation of related complaints.Amendment: this follow-up report is being submitted to amend previously reported information: this case has been considered a reportable malfunction.Evaluation codes were also updated.Follow-up (13dec2019): new information received from a product quality complaint group included: site sample status, additional class/subclass, and no impact on regulatory, product quality, and market/clinical and stability.Follow-up (16jan2020): new information received from a product quality complaint group included: investigation results.Follow-up (11may2020): new information received from a product quality complaint group included: additional investigation results for subclass adverse event safety request for investigation.Follow-up attempts are completed.No further information is expected., comment: based on the information provided, the events skin abrasion and device adhesion issue as described is considered serious bodily injury potentially requiring medical intervention to prevent permanent damage or impairment of body structure.Event device use issue is non-serious.The events are medically assessed as associated with the use of the device.Company conducted an investigation, the most probable root cause for this event was classified (equipment: open pouches).The severity of pouch leaks is s1, no harm to customer.Capa was implemented, and no further action is recommended.
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Search Alerts/Recalls
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