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| Lot Number W92738 |
| Device Problem
Use of Device Problem (1670)
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| Patient Problem
Patient Problem/Medical Problem (2688)
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Event Type
Injury
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Event Description
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Event verbatim [preferred term] she peeled off the back and pressed all the charcoal pockets to wake it up and place above her tailbone.Uses the neck pain therapy on her lower back [intentional device use issue] ,.Case narrative: this is a spontaneous report from a contactable consumer.This (b)(6) year-old female consumer started to receive thermacare heatwrap (thermacare neck, shoulder & wrist) lot number w92738, expiration date nov 2020, from unknown date for back ache.Medical history included blood pressure abnormal.Concomitant medication included ongoing lisinopril orally at 1 tablet daily for blood pressure.Consumer had the thermacare heatwraps neck, wrist, and shoulder pain relief.She had been using the product for a long time.In the box she recently purchased, the heat cells of the wraps were hard in (b)(6) 2019.She peeled off the back and pressed all the charcoal pockets to wake it up and place above her tailbone.She used the neck pain therapy on her lower back.She used the neck pain therapy wraps for her lower back and had been using them like this since maybe she was (b)(6) initially.Later clarified and stated between the ages of (b)(6).She did not know.It's been between the last 10 years and it sometimes it depended on the weather.Sometimes she did not know if it was the air pressure that day, but if it's raining and cold her back aches more.There were some days she did not wear the wraps at all.If her back hurt she used them and she usually bought 4 boxes at a time.Upon follow up on 29apr2019, the patient did not receive treatment due to event "the cells were hard".The patient was hospitalization due to event "uses the neck pain therapy on her lower back" but received no treatment.The action taken in response to the event of the product was unknown.The outcome of the event was resolved.Additional information has been requested and will be provided as it becomes available.Follow-up (29apr2019): new information received from a contactable consumer included: event details (patient did not receive treatment due to event "the cells were hard".The patient was hospitalization due to event "uses the neck pain therapy on her lower back" but received no treatment).Company clinical evaluation comment: based on the information provided, the event of intentional device use issue as described is considered serious bodily injury potentially requiring medical intervention to prevent permanent damage or impairment of body structure.The event is medically assessed as associated with the use of the device., comment: based on the information provided, the event of intentional device use issue as described is considered serious bodily injury potentially requiring medical intervention to prevent permanent damage or impairment of body structure.The event is medically assessed as associated with the use of the device.
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Manufacturer Narrative
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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.Capa: the (site name) consumer site 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.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.
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Event Description
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Event verbatim [preferred term] she peeled off the back and pressed all the charcoal pockets to wake it up and place above her tailbone.Uses the neck pain therapy on her lower back [intentional device use issue].Case narrative:this is a spontaneous report from a contactable consumer.This 76-year-old female consumer started to receive thermacare heatwrap (thermacare neck, shoulder & wrist) lot number w92738, expiration date nov2020, from unknown date for back ache.Medical history included ongoing blood pressure abnormal.Concomitant medication included ongoing lisinopril orally at 1 tablet daily for blood pressure.She used the neck pain therapy wraps for her lower back and had been using them like this since "between the ages of 65-70." it's been between the last 10 years and it sometimes it depended on the weather.Sometimes she did not know if it was the air pressure that day, but if it's raining and cold her back aches more.There were some days she did not wear the wraps at all.If her back hurt she used them and she usually bought 4 boxes at a time.In the box she recently purchased, the heat cells of the wraps were hard in (b)(6) 2019.She peeled off the back and pressed all the charcoal pockets to wake it up and place above her tailbone.Also reported "i bought two packs of heat wraps from a pharmacy on an unknown date.I tried the neck pain therapy, put it on and waited and waited no heat at all.Package wasn't opened that i could see but it sure wasn't correct.The second one i opened was just fine.When i purchased it, they are still good, but when i went in the box to use one, the package was already opened, it was like it had a cut in it and i thought i will try, i put it on my back, nothing happened, and the other two in the box, they look like they are compromised also.I opened the package it did not work i threw the thermacare in the garbage because it did not work." stated she may purchase the one for her neck and if her issue has nothing to do with her neck and places it on her lower back because that is all she can buy "they are not always 3-4 sizes to choose from, and women can be more petite than a man and even if not supposed to go on one part of the body it fits better.Even a shoulder one can fit on the back.The size does not matter much, you can pretty much place it anywhere." her main issue is they are not getting hot or hot enough anymore, and confirmed this issue is universal with all these heatwraps reporting on.Also reported stated it is across the board with the ones getting they don't stick or don't heat up.Stated she has tried the ones for the back, joint, and sport multipurpose, and later provided she has used ones for neck pain and back pain.They are not working at all.Explained the heatwraps have all been disappointing.None have been staying warm enough to be a benefit.Before when she used to use the heatwraps they heated and lasted for 8 hours.Explained some of the heatwraps are not heating at all until crumble them trying to break it up.It is like a hard pack, hard rocks all inside of them.When she purchased this last the pack was not sealed and the wrap packaging was open and it's pretty much useless.She states the box was sealed but the wraps were open, she has thrown away one of the wraps.The patient did not receive treatment due to event "the cells were hard".The patient was hospitalization due to event "uses the neck pain therapy on her lower back" but received no treatment.Consumer was unable to provide the ndc, upc and udi number as consumer did not have the box.Packaging was sealed and intact and she had to rip open the package.It was reported sample of the product was available to be returned.The action taken in response to the event of the product was unknown.The outcome of the event was resolved.Additional information received from product quality complaint (pqc) group included investigation results.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.Capa: the consumer site will purchase and install three 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.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 new heat seal flow wrapper machines in both production lines.Follow-up (29apr2019): new information received from a contactable consumer included: event details (patient did not receive treatment due to event "the cells were hard".The patient was hospitalization due to event "uses the neck pain therapy on her lower back" but received no treatment).Follow-up (13aug2019): new information received from a product quality complaint group included: investigation results.Follow-up (30sep2019): new information received from a product quality complaint group included: event details that package was opened, event details "purchase the one for her neck and if her issue has nothing to do with her neck and places it on her lower back/shoulder one can fit on the back", product complaints (don't stick, are not heating, hard pack/hard rocks, not working), and sample available.Company clinical evaluation comment: based on the information provided, the event of intentional device use issue as described is considered serious bodily injury potentially requiring medical intervention to prevent permanent damage or impairment of body structure.The event is medically assessed as associated with the use of the device.The review of the lot/batch records does not suggest a defect or quality issue related to the manufacture of this lot.No device malfunction has been identified.No remedial action/corrective action/field safety corrective action is suggested at this time., comment: based on the information provided, the event of intentional device use issue as described is considered serious bodily injury potentially requiring medical intervention to prevent permanent damage or impairment of body structure.The event is medically assessed as associated with the use of the device.The review of the lot/batch records does not suggest a defect or quality issue related to the manufacture of this lot.No device malfunction has been identified.No remedial action/corrective action/field safety corrective action is suggested at this time.
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Manufacturer Narrative
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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.Capa: the (site name) consumer site 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.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.
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Event Description
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Event verbatim [preferred term] she peeled off the back and pressed all the charcoal pockets to wake it up and place above her tailbone.Uses the neck pain therapy on her lower back [intentional device use issue] ,.Case narrative:this is a spontaneous report from a contactable consumer.This 76-year-old female consumer started to receive thermacare heatwrap (thermacare neck, shoulder & wrist) lot number w92738, expiration date nov2020, from unknown date for back ache.Medical history included ongoing blood pressure abnormal.Concomitant medication included ongoing lisinopril orally at 1 tablet daily for blood pressure.Consumer had the thermacare heatwraps neck, wrist, and shoulder pain relief.She had been using the product for a long time.In the box she recently purchased, the heat cells of the wraps were hard in mar/apr2019.She peeled off the back and pressed all the charcoal pockets to wake it up and place above her tailbone.She used the neck pain therapy on her lower back.She used the neck pain therapy wraps for her lower back and had been using them like this since maybe she was 65 initially.Later clarified and stated between the ages of 65-70.She did not know.It's been between the last 10 years and it sometimes it depended on the weather.Sometimes she did not know if it was the air pressure that day, but if it's raining and cold her back aches more.There were some days she did not wear the wraps at all.If her back hurt she used them and she usually bought 4 boxes at a time.Upon follow up on 29apr2019, the patient did not receive treatment due to event "the cells were hard".The patient was hospitalization due to event "uses the neck pain therapy on her lower back" but received no treatment.The action taken in response to the event of the product was unknown.The outcome of the event was resolved.Additional information received from product quality complaint (pqc) group included investigation results.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.Capa: the (site name) consumer site 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.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 (29apr2019): new information received from a contactable consumer included: event details (patient did not receive treatment due to event "the cells were hard".The patient was hospitalization due to event "uses the neck pain therapy on her lower back" but received no treatment).Follow-up (13aug2019): new information received from a product quality complaint group included: investigation results.Company clinical evaluation comment: based on the information provided, the event of intentional device use issue as described is considered serious bodily injury potentially requiring medical intervention to prevent permanent damage or impairment of body structure.The event is medically assessed as associated with the use of the device.The review of the lot/batch records does not suggest a defect or quality issue related to the manufacture of this lot.No device malfunction has been identified.No remedial action/corrective action/field safety corrective action is suggested at this time., comment: based on the information provided, the event of intentional device use issue as described is considered serious bodily injury potentially requiring medical intervention to prevent permanent damage or impairment of body structure.The event is medically assessed as associated with the use of the device.The review of the lot/batch records does not suggest a defect or quality issue related to the manufacture of this lot.No device malfunction has been identified.No remedial action/corrective action/field safety corrective action is suggested at this time.
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Search Alerts/Recalls
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