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| Lot Number AT1284 |
| Device Problems
Loss of or Failure to Bond (1068); Insufficient Heating (1287); Patient-Device Incompatibility (2682)
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| Patient Problems
Hypersensitivity/Allergic reaction (1907); Itching Sensation (1943); Rash (2033)
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Event Type
Injury
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Manufacturer Narrative
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Summary investigation severity of harm: s3 no device malfunction for rash/allergic reaction.Additional information received from the product quality complaint group (08nov2019) 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.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.There is not a trend identified for the subclass of adverse event/serious/unknown for lbh product.Additional information received from the product quality complaint group (12nov2019) open pouch investigation and root cause: 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.Complaints related to pouch sea have been thorough y investigated and root cause is well understood.Summary for drug safety unit (dsu) the root cause for never worked, too cool, did not last long enough and squeeze tube complaints.
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Event Description
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Broke him out /he was itching because he is allergic to everything [dermatitis allergic] , would not heat up or latch to his back/not latching for either box, /straps weren't strapping [device adhesion issue], broke him out /he was itching because he is allergic to everything [pruritus].Case narrative:this is a spontaneous report from a contactable consumer.A (b)(6) male patient started to receive thermacare heatwrap (thermacare lower back & hip) l/xl, two boxes with two patches each box, also reported he purchased two of the bigger boxes that contained 4-6 wraps each (clarification pending), device lot number aw808, expiration date 28feb2022 and device number at1284, expiration date 28feb2028 from an unspecified date to an unspecified date for an unspecified indication.The patient medical history and concomitant medications were not reported.The consumer reported thermacare heatwraps for lower back would not heat up or 'latch to his back'.They were not latching for either box, straps weren't strapping together.Thermacare heat wrap 'broke him out' and made him itch because he is allergic to everything on an unspecified date.Consumer reported he received something in the mail saying they wanted the product.The information also stated the 'lot number provided did not match up'.He cannot provide the upc, udi, lot or expiration date for one of the boxes because it was discarded.Consumer confirmed the packaging was sealed and intact.The consumer stated he will be sending back one of the wraps.The action taken with thermacare heatwrap and the outcome of the event was not reported.According to the product quality complaint group (06nov2019) summary investigation severity of harm: s3.Additional information received from the product quality complaint group (08nov2019) 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.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.There is not a trend identified for the subclass of adverse event/serious/unknown for lbh product.Additional information received from the product quality complaint group (12nov2019): open pouch investigation and root cause: 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.Complaints related to pouch sea have been thoroughly investigated and root cause is well understood.Summary for drug safety unit (dsu): the root cause for never worked, too cool, did not last long enough and squeeze tube complaint sub classes 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 si no harm to customer.The severity of harm was assessed as s3 for broke him out /allergic to everything and the severity of harm was assessed as s1 for they are not latching for either box.Company clinical evaluation comment based on the information provided, the event of "rash/allergic reaction" as described is considered serious bodily injury potentially requiring medical intervention to prevent permanent damage or impairment of body structure.Remaining events of device adhesion issue and itching are considered non-serious.The events are medically assessed as associated with the use of the device.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.Product effect varies with each individual.No remedial action/corrective action/field safety corrective action is suggested at this time.Comment: based on the information provided, the event of "rash/allergic reaction" as described is considered serious bodily injury potentially requiring medical intervention to prevent permanent damage or impairment of body structure.Remaining events of device adhesion issue and itching are considered non-serious.The events are medically assessed as associated with the use of the device.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.Product effect varies with each individual.No remedial action/corrective action/field safety corrective action is suggested at this time.
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Manufacturer Narrative
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Open pouch investigation and root cause: 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.Complaints related to pouch sea have been thoroughly investigated and root cause is well understood.Summary is as follows: the root cause for never worked, too cool, did not last long enough and squeeze tube complaint sub classes 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, s3 for broke him out /allergic to everything and s1 for they are not latching for either box.Also provided following report on adhesion/fastening defect on 04dec2019: lot 'aw808' is invalid per sap.Upc number: 305733010037.Summary of investigation: this investigation was conducted for an unknown lot number lower back/hip (lbh) 8-hour product.There was limited device specific information provided, no batch number or return sample was available for evaluation.Without a batc.
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Event Description
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Event verbatim [preferred term] broke him out /he was itching because he is allergic to everything [dermatitis allergic] , would not heat up or latch to his back/not latching for either box, /straps weren't strapping [device adhesion issue] , broke him out /he was itching because he is allergic to everything [pruritus].Case narrative:this is a spontaneous report from a contactable consumer.A 34-year-old male patient started to receive thermacare heatwrap (thermacare lower back & hip) l/xl, two boxes with two patches each box, also reported he purchased two of the bigger boxes that contained 4-6 wraps each (clarification pending), device lot number 'aw808', expiration date 28feb2022 and device number at1284, expiration date 28feb2028 from an unspecified date for an unspecified indication.The patient's medical history and concomitant medications were not reported.The consumer reported thermacare heatwraps for lower back would not heat up or 'latch to his back'.They were not latching for either box, straps weren't strapping together.Thermacare heat wrap 'broke him out' and made him itch because he is allergic to everything on an unspecified date.He received something in the mail saying they wanted the product, and also stated the 'lot number provided did not match up'.The boxes were discarded.The packaging was sealed and intact.The consumer will be sending back one of the wraps.Action taken with thermacare heatwrap and the outcome of the event was not reported.The product quality complaint group provided following report: information received on 08nov 2019 which includes 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.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.There is not a trend identified for the subclass of adverse event/serious/unknown for lbh product.Additional information received on 12nov2019, open pouch investigation and root cause: 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.Complaints related to pouch sea have been thoroughy investigated and root cause is well understood.Summary is as follows: the root cause for never worked, too cool, did not last long enough and squeeze tube complaint sub classes 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, s3 for broke him out /allergic to everything and s1 for they are not latching for either box.Also provided following report on adhesion/fastening defect on (b)(6) 2019: lot 'aw808' is invalid per sap.Upc number: 305733010037.Summary of investigation: this investigation was conducted for an unknown lot number lower back/hip (lbh) 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.An evaluation was made by searching for possible trends for this subclass requiring investigation by the site.The following complaint intake, triage and investigation (citi) search was performed: scope: date contacted: 14oct2016 through 14oct2019 /manufacturing site: administration/complaint sub class: adhesion/fastening defect.The citi search returned a total 460 complaints for the lower back/hip (lbh) 8hr products during this time period for the class/subclass.None were confirmed to have a manufacturing process root cause for a complaint of adhesion/fastening defect.A visual examination was performed to identify a potential trend.A trend was not identified.In order to determine if a trend exist, a citi search was conducted for the subclass adhesion/fastening defect for lbh 8hr products.The data did not show an increase over time 36 months.There is not a trend identified for the subclass adhesion/fastening defect for lbh 8hr products.There is no further action required.Site sample status: not received.Follow up (04dec2019): new information received from a product quality complaint group included: upc number, lot aw080 is invalid, investigation summary and conclusion for subclass adhesion/fastening defect.Company clinical evaluation comment: based on the information provided, the event dermatitis allergic as described is considered serious bodily injury potentially requiring medical intervention to prevent permanent damage or impairment of body structure.Remaining events device adhesion issue and itching are considered non-serious.The events are 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 dermatitis allergic as described is considered serious bodily injury potentially requiring medical intervention to prevent permanent damage or impairment of body structure.Remaining events device adhesion issue and itching are considered non-serious.The events are 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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Event Description
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Event verbatim [preferred term] broke him out /he was itching because he is allergic to everything [dermatitis allergic], broke him out /he was itching because he is allergic to everything [pruritus], , narrative: this is a spontaneous report from a contactable consumer.A 34-year-old male patient started to receive thermacare heatwrap (thermacare lower back & hip) l/xl, two boxes with two patches each box, also reported he purchased two of the bigger boxes that contained 4-6 wraps each (clarification pending), device lot number 'aw808', expiration date 28feb2022 (lot confirmed as invalid) and device number at1284, expiration date 28feb2028 from an unspecified date for an unspecified indication.The patient's medical history and concomitant medications were not reported.The consumer reported thermacare heatwraps for lower back would not heat up or 'latch to his back'.They were not latching for either box, straps weren't strapping together.Thermacare heat wrap 'broke him out' and made him itch because he is allergic to everything on an unspecified date.He received something in the mail saying they wanted the product, and also stated the 'lot number provided did not match up'.The boxes were discarded.The packaging was sealed and intact.The consumer will be sending back one of the wraps.Action taken with thermacare heatwrap and the outcome of the event was not reported.The product quality complaint group provided following report: information received on 08nov2019 which includes 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.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.There is not a trend identified for the subclass of adverse event/serious/unknown for lbh product.Additional information received on 12nov2019, open pouch investigation and root cause: 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.Complaints related to pouch sea have been "thoroughly" investigated and root cause is well understood.Summary is as follows: the root cause for never worked, too cool, did not last long enough and squeeze tube complaint sub classes 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, s3 for broke him out /allergic to everything and s1 for they are not latching for either box.Also provided following report on adhesion/fastening defect on 04dec2019: lot 'aw808' is invalid per sap.Upc number: 305733010037.Summary of investigation: this investigation was conducted for an unknown lot number lower back/hip (lbh) 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.An evaluation was made by searching for possible trends for this subclass requiring investigation by the site.The following complaint intake, triage and investigation (citi) search was performed: scope: date contacted: 14oct2016 through 14oct2019 /manufacturing site: administration/complaint sub class: adhesion/fastening defect.The citi search returned a total 460 complaints for the lower back/hip (lbh) 8hr products during this time period for the class/subclass.None were confirmed to have a manufacturing process root cause for a complaint of adhesion/fastening defect.A visual examination was performed to identify a potential trend.A trend was not identified.In order to determine if a trend exist, a citi search was conducted for the subclass adhesion/fastening defect for lbh 8hr products.The data did not show an increase over time 36 months.There is not a trend identified for the subclass adhesion/fastening defect for lbh 8hr products.There is no further action required.Site sample status: not received.According to product quality complaint group, this investigation was conducted for an unknown lot number of lower back/hip (lbh).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 available.The returned sample evaluation did not provide any additional information to help determine why the consumer stated "wrap broke his back out ".Without a batch reference number 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/serious/unknown.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 assessment and rationale: a lot trend was not performed.The lot number is unknown.Expedite trend assessment and rationale: an evaluation was made by searching for possible trends for this subclass requiring investigation by the site.Based on this citi search, there is not a trend identified for the subclass of adverse event/serious/unknown, adverse event safety request for investigation and adverse negligible-minor.Site sample status was received at the site.Follow up (04dec2019): new information received from a product quality complaint group included: upc number, lot aw080 is invalid, investigation summary and conclusion for subclass adhesion/fastening defect.Follow-up (27jan2020): follow-up attempts are completed.No further information is expected.Follow-up (02sep2020): new information received from a product quality complaint group included: investigation result for returned sample.Follow-up attempts completed.No further information expected.
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Manufacturer Narrative
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Open pouch investigation and root cause: 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.Complaints related to pouch sea have been "thoroughly" investigated and root cause is well understood.Summary is as follows: the root cause for never worked, too cool, did not last long enough and squeeze tube complaint sub classes 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, s3 for broke him out /allergic to everything and s1 for they are not latching for either box.Also provided following report on adhesion/fastening defect on 04dec2019: lot 'aw808' is invalid per sap.Upc number: 305733010037.Summary of investigation: this investigation was conducted for an unknown lot number lower back/hip (lbh) 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.An evaluation was made by searching for possible trends for this subclass requiring investigation by the site.The following complaint intake, triage and investigation (citi) search was performed: scope: date contacted: 14oct2016 through 14oct2019 /manufacturing site: administration/complaint sub class: adhesion/fastening defect.The citi search returned a total 460 complaints for the lower back/hip (lbh) 8hr products during this time period for the class/subclass.None were confirmed to have a manufacturing process root cause for a complaint of adhesion/fastening defect.A visual examination was performed to identify a potential trend.A trend was not identified.In order to determine if a trend exist, a citi search was conducted for the subclass adhesion/fastening defect for lbh 8hr products.The data did not show an increase over time 36 months.There is not a trend identified for the subclass adhesion/fastening defect for lbh 8hr products.There is no further action required.Site sample status: not received.This investigation was conducted for an unknown lot number of lower back/hip (lbh).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 available.The returned sample evaluation did not provide any additional information to help determine why the consumer stated "wrap broke his back out ".Without a batch reference number 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/serious/unknown.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 assessment and rationale: a lot trend was not performed.The lot number is unknown.Expedite trend assessment and rationale: an evaluation was made by searching for possible trends for this subclass requiring investigation by the site.Based on this citi search, there is not a trend identified for the subclass of adverse event/serious/unknown, adverse event safety request for investigation and adverse negligible-minor.Site sample status was received at the site.
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Search Alerts/Recalls
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