MAUDE Adverse Event Report: PFIZER CONSUMER HEALTH CARE THERMACARE LOWER BACK & HIP; DISPOSABLE PACK, HOT

PFIZER CONSUMER HEALTH CARE THERMACARE LOWER BACK & HIP; DISPOSABLE PACK, HOT

Lot Number DE4866;DK2631

Device Problems Insufficient Heating (1287); Unsealed Device Packaging (1444); Use of Device Problem (1670); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Inadequate Pain Relief (2388)

Event Type malfunction

Event Description

Use the back pain wraps on her wrists [device use error], cut it and wrap it around and it works well for her [intentional device misuse], narrative: this is a spontaneous report from a contactable health care professional (nurse) reporting for herself.A (b)(6) years-old female patient started to receive thermacare heatwrap (thermacare lower back & hip) 'back pain therapy, l-xl' 1 box with device lot number dk2631, expiration date jan2023 and 2 boxes with lot number: de4866, expiration date: dec2022, upc code was the same on all 3 boxes, used on her back from an unspecified date to an unspecified date for back pain, and on her wrist from an unspecified date to an unspecified date for tendinitis.The patient medical history and concomitant medications were not reported.The patient reported a few years back, she has gotten a couple that were not sealed so wrap didn't work; didn't heat up.She never checked the boxes or the wrappers, she would just put it on and then go to work and would notice that it wasn't heating up.She found out by accident that one wrapper was opened about 1/2 inch on one side, so now she started checking the boxes.She always checks the packages now to make sure the seals are correct.States that to better describe it, on the edges of each package, it shows the scissor cut, that's where it's opened about an inch on the packages; one of them was opened almost all the way; it's like the machine didn't come down to seal it.She purchased 12 boxes this week, she has 3 boxes, with 2 wraps in each box, and all 6 wraps the seal was not completely sealed so the wraps are no good.She stated she has kept 1 wrap from each box.When she puts one on she depends on it to work.Sometimes use the back pain wraps on her wrists, for her tendinitis if that's all she has.She will just cut it and wrap it around and it works well for her.The action taken with thermacare heatwrap was unknown.The clinical outcome of the event was unknown.A sample of the product is available to be returned.Packaging sealed and intact? yes for the boxes, but no for the wrappers.Additional information has been requested and will be provided as it becomes available.No follow-up attempts are needed.No further information is expected.

Manufacturer Narrative

11sep2020: reasonably suggest device malfunction: yes.Severity of harm: s1.Site sample status: not received.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, 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 primary container damage and defect not classified.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.28sep2020: product: thermacare lower back & hip.Lot number and expiration date: dk2631 and jan2023.Description of compliant: "sometimes use the back pain wraps on her wrists, for her tendinitis if that's all she has".Complaint sub-class: adverse event/negligible-minor.Reasonably suggest device malfunction: no.Severity of harm: n/a.Site sample status: not received.Conclusion: the root cause category is non assignable (complaint not confirmed as a quality defect).After a review of the batch thermal records, thermal results all met product release criteria.Consumer reports "sometimes use the back pain wraps on her wrists, for her tendinitis if that's all she has." the reviewof records does not provide evidence to support defective products.The complaint can not be confirmed.The product effect may vary with each individual.The plant has reviewed this batch from a manufacturing perspective.No quality issues were identified upon this review of batch records, release testing data or, an inspection of retained samples.Retained samples met the product description, and the product is within the expiration date.This complaint does not impact the product quality for the batch.Lot trend assmt.& rationale: an evaluation of the complaint history confirms that this is the first complaint for the sub class adverse event/negligible-minor received at the albany site requiring an evaluation for this lot.A visual evaluation was performed to identify a potential trend for the lot and subclass.A trend was not identified.On this basis, a trend does not exist for this batch.Exped trend assmt.& rationale: an evaluation was made by searching for possible trend for this subclass.Exped trend actions taken: based on this citi search, there is not a trend identified for the subclass adverse event negligible-minor for lbh 8hr products, refer to attached trending chart lbh adverse event/negligible-minor (b)(6) 2017 to (b)(6) 2020.There is no further action is required.02dec2020: investigation reopen to add return sample evaluation.Batch code#: de4866.Date of manufacture: 02jan2020 to 10jan2020.Batch de4866 is the only batch within the scope of this investigation.Thermacare batches are produced as individual lots.The device history record (dhr), reserve samples, and trending were evaluated.No quality issues were identified.Process related was no.Final confirmation status was not confirmed.Conclusion: the root cause category is non assignable (complaint not confirmed as a quality defect).After a review of the batch thermal records, thermal results all met product release criteria.Evaluation of the consumer return sample does not confirm the complaint.Consumer reported "used on her back from an unspecified date to an unspecified date for back pain, and on her wrist.¿ care should be taken when using the device, following all safety and use information as provided with the wrap to avoid any health risk.The plant has reviewed this batch from a manufacturing perspective.No quality issues were identified upon this review of batch records, release testing data or, inspection of retained samples.Retained samples met the product description and the product is within expiration date.The product quality for the batch is not impacted by this complaint.Lot trend assmt.& rationale: an evaluation of the complaint history confirms that this is the second complaint for the sub class adverse event/negligible-minor received at the albany site requiring an evaluation for this lot.On this basis, a trend does not exist for this batch.Exped trend assmt.& rationale: an evaluation was made by searching for possible trend for this subclass.Based on this citi customizable search for the subclasses of adverse event/negligible-minor for lbh products the data did not show an increase over time (36 months).There is not a trend identified for the subclass of adverse event/negligible-minor for lbh product, refer to attachment lbh adverse event negligible-minor (b)(6) 2017 to (b)(6) 2020.Site sample status was received at the site.Date samples was received (gmt) was on 09sep2020.Return sample evaluation: 5 wraps: wraps are inside partially sealed pouches.All wraps have expired.All five pouches have incomplete seals on both ends.2 cartons: both cartons are open.Evaluation of consumer return sample shows incomplete pouch sealing for all five (5) wraps returned.A pouch with incomplete pouch sealing results in a wrap that does not heat up.The root cause of open pouches is equipment and corrective actions and preventive actions (capas) have been established per cd-#, evaluation of complaints related to open pouches, effective 19nov2020.

Event Description

Event verbatim [preferred term], use the back pain wraps on her wrists [device use issue], cut it and wrap it around and it works well for her/wears one wrap in the day and a second wrap at night [intentional device misuse], narrative: this is a spontaneous report from a contactable health care professional licensed practical nurse (lpn) reporting for herself.A female patient of an unspecified age (currently 72-year-old) started to receive thermacare heatwrap (thermacare lower back & hip) 'back pain therapy, l-xl' 1 box with device lot number dk2631, expiration date jan2023 and 2 boxes with lot number: de4866, expiration date: dec2022, upc code was the same on all 3 boxes, used on her back from an unspecified date to an unspecified date for back pain, and on her wrist from an unspecified date to an unspecified date for tendinitis.The patient medical history and concomitant medications were not reported.The patient reported a few years back, she had gotten a couple that were not sealed so wrap didn't work; didn't heat up.She never checked the boxes or the wrappers, she would just put it on and then go to work and would notice that it wasn't heating up.She found out by accident that one wrapper was opened about 1/2 inch on one side, so now she started checking the boxes.She always checked the packages to make sure the seals were correct.The patient stated that to better describe it, on the edges of each package, it showed the scissor cut, that was where it was opened about an inch on the packages; one of them was opened almost all the way; it was like the machine didn't come down to seal it.The consumer reported she wore one wrap in the day and a second wrap at night and had worn them like this for years.She purchased 12 boxes this week (usually buys 12 boxes per week), she had 3 boxes, with 2 wraps in each box, and all 6 wraps the seal was not completely sealed so the wraps were no good.She stated she had kept 1 wrap from each box.When she put one on she depended on it to work.Sometimes used the back pain wraps on her wrists for her tendinitis; if that was all she had.She would just cut it and wrap it around and it worked well for her.Consumer stated that she did receive the mailer but since her last call to pfizer, she found two more boxes of thermacare heatwraps with the same problem.Almost all the bags were ruptured.She had 8 boxes of thermacare that were already activated because the wrapper wasn't completely sealed.The individual packs were popped open and exposed to air.Consumer did not use them because when they were exposed to air they were hard and non-usable.She put the new ones that were popped open in with the original product complaint wraps to send back to pfizer.The box was discarded and doesn't know the upc, lot or expiration date for the additional product.She had everything set up to send back and has requested a refund.The action taken with thermacare heatwrap was unknown.The clinical outcome of the event was unknown.Packaging was sealed and intact for the boxes, but no for the wrappers.The patient had already sent the products back, 8 packages, that had split.They did not seal properly.She put them all in the box and sent the boxes.On 11sep2020, according to the product quality control group: in 2013 a complaint trend was opened for the pouch seal defect.The trend directly correlates with the implementation of ultrasonic heat seal technology.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 defeat 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 thermal seal, critical to the functionality and longevity of the thermacare care product.The root cause for never worked, too cool did not long enough and squeeze tube complaint sub classless is due to a pouch (primary packing) that did not seal completely (open pouch).An open pouch will expose the wrap to air before the consumer; specifically ultrasonic technology.The corrective action is to purchase and install three (3) new heat seal flow wrapper machines in both production lines.Capa is in-place to replace the ultrasonic sealers with heat seal technology.Device history record (dhr) is not reviewed for an unknown batch number.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, 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 primary container damage and defect not classified.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.Reasonably suggest device malfunction: yes.Severity of harm: s1.Site sample status: not received.On 28sep2020, the product quality complaint group provided the following investigation results that yielded no product quality issues.Product: thermacare lower back & hip.Lot number and expiration date: dk2631 and jan2023.Description of compliant: "sometimes use the back pain wraps on her wrists, for her tendinitis if that's all she has".Complaint sub-class: adverse event/negligible-minor.Reasonably suggest device malfunction: no.Severity of harm: n/a.Site sample status: not received.Summary of investigation: batch dk2631 is the only batch within the scope of this investigation.Thermacare batches are produced as individual lots.The device history record (dhr), reserve samples, and trending were evaluated.No quality issues were identified.Root cause/capa: process related: no; final confirmation status: not confirmed; root cause category: non-assignable (complaint not confirmed).Conclusion: the root cause category is non assignable (complaint not confirmed as a quality defect).After a review of the batch thermal records, thermal results all met product release criteria.Consumer reports "sometimes use the back pain wraps on her wrists, for her tendinitis if that's all she has." the reviewof records does not provide evidence to support defective products.The complaint can not be confirmed.The product effect may vary with each individual.Care should be taken when using the device, following all safety and use information as provided with the wrap to avoid any health risk.The plant has reviewed this batch from a manufacturing perspective.No quality issues were identified upon this review of batch records, release testing data or, an inspection of retained samples.Retained samples met the product description, and the product is within the expiration date.This complaint does not impact the product quality for the batch.Lot trend assmt.& rationale: an evaluation of the complaint history confirms that this is the first complaint for the sub class adverse event/negligible-minor received at the albany site requiring an evaluation for this lot.A visual evaluation was performed to identify a potential trend for the lot and subclass.A trend was not identified.On this basis, a trend does not exist for this batch.Exped trend assmt.& rationale: an evaluation was made by searching for possible trend for this subclass.Exped trend actions taken: based on this citi search, there is not a trend identified for the subclass adverse event negligible-minor for lbh 8hr products, refer to attached trending chart lbh adverse event/negligible-minor (b)(6) 2017 to (b)(6) 2020.There is no further action is required.According to the product quality complaint group on 02dec2020: investigation reopen to add return sample evaluation.Batch code#: de4866.Date of manufacture: 02jan2020 to 10jan2020.Batch de4866 is the only batch within the scope of this investigation.Thermacare batches are produced as individual lots.The device history record (dhr), reserve samples, and trending were evaluated.No quality issues were identified.Process related was no.Final confirmation status was not confirmed.Conclusion: the root cause category is non assignable (complaint not confirmed as a quality defect).After a review of the batch thermal records, thermal results all met product release criteria.Evaluation of the consumer return sample does not confirm the complaint.Consumer reported "used on her back from an unspecified date to an unspecified date for back pain, and on her wrist." care should be taken when using the device, following all safety and use information as provided with the wrap to avoid any health risk.The plant has reviewed this batch from a manufacturing perspective.No quality issues were identified upon this review of batch records, release testing data or, inspection of retained samples.Retained samples met the product description and the product is within expiration date.The product quality for the batch is not impacted by this complaint.Lot trend assmt.& rationale: an evaluation of the complaint history confirms that this is the second complaint for the sub class adverse event/negligible-minor received at the albany site requiring an evaluation for this lot.On this basis, a trend does not exist for this batch.Exped trend assmt.& rationale: an evaluation was made by searching for possible trend for this subclass.Based on this citi customizable search for the subclasses of adverse event/negligible-minor for lbh products the data did not show an increase over time (36 months).There is not a trend identified for the subclass of adverse event/negligible-minor for lbh product, refer to attachment lbh adverse event negligible-minor (b)(6) 2017 to (b)(6) 2020.Site sample status was received at the site.Date samples was received (gmt) was on 09sep2020.Return sample evaluation: 5 wraps: wraps are inside partially sealed pouches.All wraps have expired.All five pouches have incomplete seals on both ends.2 cartons: both cartons are open.Evaluation of consumer return sample shows incomplete pouch sealing for all five (5) wraps returned.A pouch with incomplete pouch sealing results in a wrap that does not heat up.The root cause of open pouches is equipment and corrective actions and preventive actions (capas) have been established per cd-#, evaluation of complaints related to open pouches, effective 19nov2020.No follow-up attempts are needed.No further information is expected.Follow-up (08sep2020, 08sep2020 and 08sep2020): additional information received from the same contactable nurse (reporting for herself) included: reporter (lpn), product complaint( found two more boxes of thermacare heat wraps popped open, exposed to air, almost all the bags were ruptured.), product usage details (wears one wrap in the day and a second wrap at night).Follow-up (11sep2020 and 14sep2020): new information received from product quality complaint group included: investigation results.No follow-up attempts are needed.No further information is expected.Follow-up (16sep2020): new information reported from a contactable nurse (reporting for herself) included device information.Tendinitis was added as additional indication.Patient's age was updated.No follow-up attempts are needed.No further information is expected.Follow-up (28sep2020): new information received from the product quality complaint group included: investigation results that yielded no product quality issues.No follow-up attempts are needed.No further information is expected.Follow-up (09oct2020): new information received from the product quality complaint group included investigational results for lot number de4866.Case amended to update operator of device to health professional.No follow up attempts are needed.No further information is expected.Follow-up (15oct2020): no follow-up attempts are needed.No further information is expected.Amendment: this follow-up report is being submitted to amend previously reported information: lot trend and exped trend were added, the event "the individual packs are popped open and exposed to air/has 8 boxes of thermacare that were already activated because the wrapper wasn't completely sealed/almost all the bags were ruptured" was deleted.Follow-up (02dec2020): new information received from the product quality complaint group included updated investigational results for lot number de4866, sample was received at the site.No follow-up attempts are needed.No further information is expected.

Event Description

Use the back pain wraps on her wrists [device use error], cut it and wrap it around and it works well for her/wears one wrap in the day and a second wrap at night [intentional device misuse], the individual packs are popped open and exposed to air/has 8 boxes of thermacare that were already activated because the wrapper wasn't completely sealed/almost all the bags were ruptured [device issue].Narrative: this is a spontaneous report from a contactable health care professional licensed practical nurse (lpn) reporting for herself.A 72-years-old female patient started to receive thermacare heatwrap (thermacare lower back & hip) 'back pain therapy, l-xl' 1 box with device lot number dk2631, expiration date jan2023 and 2 boxes with lot number: de4866, expiration date: dec2022, upc code was the same on all 3 boxes, used on her back from an unspecified date to an unspecified date for back pain, and on her wrist from an unspecified date to an unspecified date for tendinitis.The patient medical history and concomitant medications were not reported.The patient reported a few years back, she has gotten a couple that were not sealed so wrap didn't work; didn't heat up.She never checked the boxes or the wrappers, she would just put it on and then go to work and would notice that it wasn't heating up.She found out by accident that one wrapper was opened about 1/2 inch on one side, so now she started checking the boxes.She always checks the packages now to make sure the seals are correct.States that to better describe it, on the edges of each package, it shows the scissor cut, that's where it's opened about an inch on the packages; one of them was opened almost all the way; it's like the machine didn't come down to seal it.The consumer reported she wears one wrap in the day and a second wrap at night and has worn them like this for years.She purchased 12 boxes this week (usually buys 12 boxes per week), she has 3 boxes, with 2 wraps in each box, and all 6 wraps the seal was not completely sealed so the wraps are no good.She stated she has kept 1 wrap from each box.When she puts one on she depends on it to work.Sometimes use the back pain wraps on her wrists for her tendinitis; if that's all she has.She will just cut it and wrap it around and it works well for her.Consumer stated that she did receive the mailer but since her last call to pfizer, she found two more boxes of thermacare heatwraps with the same problem.Almost all the bags were ruptured.She has 8 boxes of thermacare that were already activated because the wrapper wasn't completely sealed.The individual packs are popped open and exposed to air.Consumer did not use them because when they are exposed to air they are hard and non-usable.She put the new ones that were popped open in with the original product complaint wraps to send back to pfizer.The box was discarded and doesn't know the upc, lot or expiration date for the additional product.She has everything set up to send back and has requested a refund.The action taken with thermacare heatwrap was unknown.The clinical outcome of the event was unknown.A sample of the product is available to be returned.Packaging sealed and intact? yes for the boxes, but no for the wrappers.According to the product quality control group in 2013 a complaint trend was opened for the pouch seal defect.The trend directly correlates with the implementation of ultrasonic heat seal technology.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 defeat 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 thermal seal, critical to the functionality and longevity of the thermacare care product.The root cause for never worked, too cool did not long enough and squeeze tube complaint sub classless is due to a pouch (primary packing) that did not seal completely (open pouch).An open pouch will expose the wrap to air before the consumer; specifically ultrasonic technology.The corrective action is to purchase and install three (3) new heat seal flow wrapper machines in both production lines.Capa is in-place to replace the ultrasonic sealers with heat seal technology.Device history record (dhr) is not reviewed for an unknown batch number.In 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, 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 primary container damage and defect not classified.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.Reasonably suggest device malfunction: yes.Severity of harm: s1.No follow-up attempts are needed.No further information is expected.Follow-up (08sep2020), (08sep2020) and (08sep2020): additional information received from the same contactable nurse (reporting for herself) included: reporter (lpn), product complaint( found two more boxes of thermacare heat wraps popped open, exposed to air, almost all the bags were ruptured.), product usage details (wears one wrap in the day and a second wrap at night).Follow-up (11sep2020) and (14sep2020): new information received from product quality complaint group included: investigation no follow-up attempts are needed.No further information is expected.

Manufacturer Narrative

According to the product quality control group in 2013 a complaint trend was opened for the pouch seal defect.The trend directly correlates with the implementation of ultrasonic heat seal technology.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 defeat 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 thermal seal, critical to the functionality and longevity of the thermacare care product.The root cause for never worked, too cool did not long enough and squeeze tube complaint sub classless is due to a pouch (primary packing) that did not seal completely (open pouch).An open pouch will expose the wrap to air before the consumer; specifically ultrasonic technology.The corrective action is to purchase and install three (3) new heat seal flow wrapper machines in both production lines.Capa is in-place to replace the ultrasonic sealers with heat seal technology.Device history record (dhr) is not reviewed for an unknown batch number.In 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, 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 primary container damage and defect not classified.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.Reasonably suggest device malfunction: yes.Severity of harm: s1.

Event Description

Event verbatim [preferred term], use the back pain wraps on her wrists [device use issue], cut it and wrap it around and it works well for her/wears one wrap in the day and a second wrap at night [intentional device misuse].Narrative: this is a spontaneous report from a contactable health care professional licensed practical nurse (lpn) reporting for herself.A female patient of an unspecified age (currently 72-year-old) started to receive thermacare heatwrap (thermacare lower back & hip) 'back pain therapy, l-xl' 1 box with device lot number dk2631, expiration date jan2023 and 2 boxes with lot number: de4866, expiration date: dec2022, upc code was the same on all 3 boxes, used on her back from an unspecified date to an unspecified date for back pain, and on her wrist from an unspecified date to an unspecified date for tendinitis.The patient medical history and concomitant medications were not reported.The patient reported a few years back, she had gotten a couple that were not sealed so wrap didn't work; didn't heat up.She never checked the boxes or the wrappers, she would just put it on and then go to work and would notice that it wasn't heating up.She found out by accident that one wrapper was opened about 1/2 inch on one side, so now she started checking the boxes.She always checked the packages to make sure the seals were correct.The patient stated that to better describe it, on the edges of each package, it showed the scissor cut, that was where it was opened about an inch on the packages; one of them was opened almost all the way; it was like the machine didn't come down to seal it.The consumer reported she wore one wrap in the day and a second wrap at night and had worn them like this for years.She purchased 12 boxes this week (usually buys 12 boxes per week), she had 3 boxes, with 2 wraps in each box, and all 6 wraps the seal was not completely sealed so the wraps were no good.She stated she had kept 1 wrap from each box.When she put one on she depended on it to work.Sometimes used the back pain wraps on her wrists for her tendinitis; if that was all she had.She would just cut it and wrap it around and it worked well for her.Consumer stated that she did receive the mailer but since her last call to pfizer, she found two more boxes of thermacare heatwraps with the same problem.Almost all the bags were ruptured.She had 8 boxes of thermacare that were already activated because the wrapper wasn't completely sealed.The individual packs were popped open and exposed to air.Consumer did not use them because when they were exposed to air they were hard and non-usable.She put the new ones that were popped open in with the original product complaint wraps to send back to pfizer.The box was discarded and doesn't know the upc, lot or expiration date for the additional product.She had everything set up to send back and has requested a refund.The action taken with thermacare heatwrap was unknown.The clinical outcome of the event was unknown.Packaging was sealed and intact for the boxes, but no for the wrappers.The patient had already sent the products back, 8 packages, that had split.They did not seal properly.She put them all in the box and sent the boxes.On 11sep2020, according to the product quality control group: in 2013 a complaint trend was opened for the pouch seal defect.The trend directly correlates with the implementation of ultrasonic heat seal technology.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 defeat 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 thermal seal, critical to the functionality and longevity of the thermacare care product.The root cause for never worked, too cool did not long enough and squeeze tube complaint sub classless is due to a pouch (primary packing) that did not seal completely (open pouch).An open pouch will expose the wrap to air before the consumer; specifically ultrasonic technology.The corrective action is to purchase and install three (3) new heat seal flow wrapper machines in both production lines.Capa is in-place to replace the ultrasonic sealers with heat seal technology.Device history record (dhr) is not reviewed for an unknown batch number.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, 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 primary container damage and defect not classified.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.Reasonably suggest device malfunction: yes.Severity of harm: s1.Site sample status: not received.On 28sep2020, the product quality complaint group provided the following investigation results that yielded no product quality issues.Product: thermacare lower back & hip.Lot number and expiration date: dk2631 and jan2023.Description of compliant: "sometimes use the back pain wraps on her wrists, for her tendinitis if that's all she has".Complaint sub-class: adverse event/negligible-minor.Reasonably suggest device malfunction: no.Severity of harm: n/a.Site sample status: not received.Summary of investigation: batch dk2631 is the only batch within the scope of this investigation.Thermacare batches are produced as individual lots.The device history record (dhr), reserve samples, and trending were evaluated.No quality issues were identified.Root cause/capa: process related: no; final confirmation status: not confirmed; root cause category: non-assignable (complaint not confirmed).Conclusion: the root cause category is non assignable (complaint not confirmed as a quality defect).After a review of the batch thermal records, thermal results all met product release criteria.Consumer reports "sometimes use the back pain wraps on her wrists, for her tendinitis if that's all she has." the reviewof records does not provide evidence to support defective products.The complaint can not be confirmed.The product effect may vary with each individual.Care should be taken when using the device, following all safety and use information as provided with the wrap to avoid any health risk.The plant has reviewed this batch from a manufacturing perspective.No quality issues were identified upon this review of batch records, release testing data or, an inspection of retained samples.Retained samples met the product description, and the product is within the expiration date.This complaint does not impact the product quality for the batch.Lot trend assmt.& rationale: an evaluation of the complaint history confirms that this is the first complaint for the sub class adverse event/negligible-minor received at the albany site requiring an evaluation for this lot.A visual evaluation was performed to identify a potential trend for the lot and subclass.A trend was not identified.On this basis, a trend does not exist for this batch.Exped trend assmt.& rationale: an evaluation was made by searching for possible trend for this subclass.Exped trend actions taken: based on this citi search, there is not a trend identified for the subclass adverse event negligible-minor for lbh 8hr products, refer to attached trending chart lbh adverse event/negligible-minor (b)(6) 2017 to (b)(6) 2020.There is no further action is required.According to the product quality complaint group on 09oct2020: product: thermacare lower back & hip.Lot number: de4866, expiration date: dec2022.Summary of investigation: batch code#: de4866; date of manufacture: 02jan2020 to 10jan2020; de4866 is the only batch within the scope of this investigation.Thermacare batches are produced as individual lots.The device history record (dhr), reserve samples, and trending were evaluated.No quality issues were identified.Conclusion: the root cause category is non assignable (complaint not confirmed as a quality defect).After a review of the batch thermal records, thermal results all met product release criteria.Consumer reported "used on her back from an unspecified date to an unspecified date for back pain, and on her wrist." review of records does not provide evidence to support defective product.Care should be taken when using the device, following all safety and use information as provided with the wrap to avoid any health risk.The plant has reviewed this batch from a manufacturing perspective.No quality issues were identified upon this review of batch records, release testing data or, inspection of retained samples.Retained samples met the product description and the product is within expiration date.The product quality for the batch is not impacted by this complaint.Lot trend assmt.& rationale: an evaluation of the complaint history confirms that this is the second complaint for the sub class adverse event/negligible-minor received at the (site name) site requiring an evaluation for this lot.Per #, complaint trending guideline, effective 24feb2020, a visual evaluation was performed to identify a potential trend for the lot and subclass.A trend was not identified.On this basis, a trend does not exist for this batch.Site sample status was not received.No follow-up attempts are needed.No further information is expected.Follow-up (08sep2020, 08sep2020 and 08sep2020): additional information received from the same contactable nurse (reporting for herself) included: reporter (lpn), product complaint( found two more boxes of thermacare heat wraps popped open, exposed to air, almost all the bags were ruptured.), product usage details (wears one wrap in the day and a second wrap at night).Follow-up (11sep2020 and 14sep2020): new information received from product quality complaint group included: investigation results.No follow-up attempts are needed.No further information is expected.Follow-up (16sep2020): new information reported from a contactable nurse (reporting for herself) included device information.Tendinitis was added as additional indication.Patient's age was updated.No follow-up attempts are needed.No further information is expected.Follow-up (28sep2020): new information received from the product quality complaint group included: investigation results that yielded no product quality issues.No follow-up attempts are needed.No further information is expected.Follow-up (09oct2020): new information received from the product quality complaint group included investigational results for lot number de4866.Case amended to update operator of device to health professional.No follow up attempts are needed.No further information is expected.Follow-up (15oct2020): no follow-up attempts are needed.No further information is expected.Amendment: this follow-up report is being submitted to amend previously reported information: lot trend and exped trend were added, the event "the individual packs are popped open and exposed to air/has 8 boxes of thermacare that were already activated because the wrapper wasn't completely sealed/almost all the bags were ruptured" was deleted.

Manufacturer Narrative

On (b)(6) 2020: reasonably suggest device malfunction: yes.Severity of harm: s1.Site sample status: not received.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, 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 primary container damage and defect not classified.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.On (b)(6) 2020: product: thermacare lower back & hip.Lot number and expiration date: dk2631 and jan2023.Description of compliant: "sometimes use the back pain wraps on her wrists, for her tendinitis if that's all she has".Complaint sub-class: adverse event/negligible-minor.Reasonably suggest device malfunction: no.Severity of harm: n/a.Site sample status: not received.Conclusion: the root cause category is non assignable (complaint not confirmed as a quality defect).After a review of the batch thermal records, thermal results all met product release criteria.Consumer reports "sometimes use the back pain wraps on her wrists, for her tendinitis if that's all she has." the reviewof records does not provide evidence to support defective products.The complaint can not be confirmed.The product effect may vary with each individual.The plant has reviewed this batch from a manufacturing perspective.No quality issues were identified upon this review of batch records, release testing data or, an inspection of retained samples.Retained samples met the product description, and the product is within the expiration date.This complaint does not impact the product quality for the batch.Lot trend assmt.& rationale: an evaluation of the complaint history confirms that this is the first complaint for the sub class adverse event/negligible-minor received at the albany site requiring an evaluation for this lot.A visual evaluation was performed to identify a potential trend for the lot and subclass.A trend was not identified.On this basis, a trend does not exist for this batch.Exped trend assmt.& rationale: an evaluation was made by searching for possible trend for this subclass.Exped trend actions taken: based on this citi search, there is not a trend identified for the subclass adverse event negligible-minor for lbh 8hr products, refer to attached trending chart lbh adverse event/negligible-minor 01-sep-2017 to 01-sep-2020.There is no further action is required.On (b)(6) 2020: product: thermacare lower back & hip.Lot number: de4866, expiration date: dec2022.Summary of investigation: batch code#: de4866; date of manufacture: 02jan2020 to on (b)(6) 2020; de4866 is the only batch within the scope of this investigation.Thermacare batches are produced as individual lots.The device history record (dhr), reserve samples, and trending were evaluated.No quality issues were identified.Conclusion: the root cause category is non assignable (complaint not confirmed as a quality defect).After a review of the batch thermal records, thermal results all met product release criteria.Consumer reported "used on her back from an unspecified date to an unspecified date for back pain, and on her wrist." review of records does not provide evidence to support defective product.Care should be taken when using the device, following all safety and use information as provided with the wrap to avoid any health risk.The plant has reviewed this batch from a manufacturing perspective.No quality issues were identified upon this review of batch records, release testing data or, inspection of retained samples.Retained samples met the product description and the product is within expiration date.The product quality for the batch is not impacted by this complaint.Lot trend assmt.& rationale: an evaluation of the complaint history confirms that this is the second complaint for the sub class adverse event/negligible-minor received at the (site name) site requiring an evaluation for this lot.Per #, complaint trending guideline, effective 24feb2020, a visual evaluation was performed to identify a potential trend for the lot and subclass.A trend was not identified.On this basis, a trend does not exist for this batch.Site sample status was not received.

Manufacturer Narrative

In 2013 a complaint trend was opened for the pouch seal defect.The trend directly correlates with the implementation of ultrasonic heat seal technology.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 defeat 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 thermal seal, critical to the functionality and longevity of the thermacare care product.The root cause for never worked, too cool did not long enough and squeeze tube complaint sub classless is due to a pouch (primary packing) that did not seal completely (open pouch).An open pouch will expose the wrap to air before the consumer; specifically ultrasonic technology.The corrective action is to purchase and install three (3) new heat seal flow wrapper machines in both production lines.Capa is in-place to replace the ultrasonic sealers with heat seal technology.Device history record (dhr) is not reviewed for an unknown batch number.In 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, 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 primary container damage and defect not classified.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.

Event Description

Event verbatim [preferred term].Use the back pain wraps on her wrists [device use error], cut it and wrap it around and it works well for her/wears one wrap in the day and a second wrap at night [intentional device misuse], the individual packs are popped open and exposed to air/has 8 boxes of thermacare that were already activated because the wrapper wasn't completely sealed/almost all the bags were ruptured [device issue] narrative: this is a spontaneous report from a contactable health care professional licensed practical nurse (lpn) reporting for herself.A female patient of an unspecified age started to receive thermacare heatwrap (thermacare lower back & hip) 'back pain therapy, l-xl' 1 box with device lot number dk2631, expiration date jan2023 and 2 boxes with lot number: de4866, expiration date: dec2022, upc code was the same on all 3 boxes, used on her back from an unspecified date to an unspecified date for back pain, and on her wrist from an unspecified date to an unspecified date for tendinitis.The patient medical history and concomitant medications were not reported.The patient reported a few years back, she had gotten a couple that were not sealed so wrap didn't work; didn't heat up.She never checked the boxes or the wrappers, she would just put it on and then go to work and would notice that it wasn't heating up.She found out by accident that one wrapper was opened about 1/2 inch on one side, so now she started checking the boxes.She always checked the packages to make sure the seals were correct.The patient stated that to better describe it, on the edges of each package, it showed the scissor cut, that was where it was opened about an inch on the packages; one of them was opened almost all the way; it was like the machine didn't come down to seal it.The consumer reported she wore one wrap in the day and a second wrap at night and had worn them like this for years.She purchased 12 boxes this week (usually buys 12 boxes per week), she had 3 boxes, with 2 wraps in each box, and all 6 wraps the seal was not completely sealed so the wraps were no good.She stated she had kept 1 wrap from each box.When she put one on she depended on it to work.Sometimes used the back pain wraps on her wrists for her tendinitis; if that was all she had.She would just cut it and wrap it around and it worked well for her.Consumer stated that she did receive the mailer but since her last call to pfizer, she found two more boxes of thermacare heatwraps with the same problem.Almost all the bags were ruptured.She had 8 boxes of thermacare that were already activated because the wrapper wasn't completely sealed.The individual packs were popped open and exposed to air.Consumer did not use them because when they were exposed to air they were hard and non-usable.She put the new ones that were popped open in with the original product complaint wraps to send back to pfizer.The box was discarded and doesn't know the upc, lot or expiration date for the additional product.She had everything set up to send back and has requested a refund.The action taken with thermacare heatwrap was unknown.The clinical outcome of the event was unknown.Packaging was sealed and intact for the boxes, but no for the wrappers.The patient had already sent the products back, 8 packages, that had split.They did not seal properly.She put them all in the box and sent the boxes.According to the product quality control group in 2013 a complaint trend was opened for the pouch seal defect.The trend directly correlates with the implementation of ultrasonic heat seal technology.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 defeat 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 thermal seal, critical to the functionality and longevity of the thermacare care product.The root cause for never worked, too cool did not long enough and squeeze tube complaint sub classless is due to a pouch (primary packing) that did not seal completely (open pouch).An open pouch will expose the wrap to air before the consumer; specifically ultrasonic technology.The corrective action is to purchase and install three (3) new heat seal flow wrapper machines in both production lines.Capa is in-place to replace the ultrasonic sealers with heat seal technology.Device history record (dhr) is not reviewed for an unknown batch number.In 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, 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 primary container damage and defect not classified.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.Reasonably suggest device malfunction: yes.Severity of harm: s1.No follow-up attempts are needed.No further information is expected.Follow-up (08sep2020), (08sep2020) and (08sep2020): additional information received from the same contactable nurse (reporting for herself) included: reporter (lpn), product complaint( found two more boxes of thermacare heat wraps popped open, exposed to air, almost all the bags were ruptured.), product usage details (wears one wrap in the day and a second wrap at night).Follow-up (11sep2020) and (14sep2020): new information received from product quality complaint group included: investigation results.No follow-up attempts are needed.No further information is expected.Follow-up (16sep2020): this is a follow-up report received from a contactable nurse (reporting for herself).New information included device information.Tendinitis was added as additional indication.Patient's age was updated.No follow-up attempts are needed.No further information is expected.

Event Description

Event verbatim [preferred term], use the back pain wraps on her wrists [device use error], cut it and wrap it around and it works well for her/wears one wrap in the day and a second wrap at night [intentional device misuse], the individual packs are popped open and exposed to air/has 8 boxes of thermacare that were already activated because the wrapper wasn't completely sealed/almost all the bags were ruptured [device issue], , narrative: this is a spontaneous report from a contactable health care professional licensed practical nurse (lpn) reporting for herself.A female patient of an unspecified age started to receive thermacare heatwrap (thermacare lower back & hip) 'back pain therapy, l-xl' 1 box with device lot number dk2631, expiration date jan2023 and 2 boxes with lot number: de4866, expiration date: dec2022, upc code was the same on all 3 boxes, used on her back from an unspecified date to an unspecified date for back pain, and on her wrist from an unspecified date to an unspecified date for tendinitis.The patient medical history and concomitant medications were not reported.The patient reported a few years back, she had gotten a couple that were not sealed so wrap didn't work; didn't heat up.She never checked the boxes or the wrappers, she would just put it on and then go to work and would notice that it wasn't heating up.She found out by accident that one wrapper was opened about 1/2 inch on one side, so now she started checking the boxes.She always checked the packages to make sure the seals were correct.The patient stated that to better describe it, on the edges of each package, it showed the scissor cut, that was where it was opened about an inch on the packages; one of them was opened almost all the way; it was like the machine didn't come down to seal it.The consumer reported she wore one wrap in the day and a second wrap at night and had worn them like this for years.She purchased 12 boxes this week (usually buys 12 boxes per week), she had 3 boxes, with 2 wraps in each box, and all 6 wraps the seal was not completely sealed so the wraps were no good.She stated she had kept 1 wrap from each box.When she put one on she depended on it to work.Sometimes used the back pain wraps on her wrists for her tendinitis; if that was all she had.She would just cut it and wrap it around and it worked well for her.Consumer stated that she did receive the mailer but since her last call to pfizer, she found two more boxes of thermacare heatwraps with the same problem.Almost all the bags were ruptured.She had 8 boxes of thermacare that were already activated because the wrapper wasn't completely sealed.The individual packs were popped open and exposed to air.Consumer did not use them because when they were exposed to air they were hard and non-usable.She put the new ones that were popped open in with the original product complaint wraps to send back to pfizer.The box was discarded and doesn't know the upc, lot or expiration date for the additional product.She had everything set up to send back and has requested a refund.The action taken with thermacare heatwrap was unknown.The clinical outcome of the event was unknown.Packaging was sealed and intact for the boxes, but no for the wrappers.The patient had already sent the products back, 8 packages, that had split.They did not seal properly.She put them all in the box and sent the boxes.On 11sep2020, according to the product quality control group :in 2013 a complaint trend was opened for the pouch seal defect.The trend directly correlates with the implementation of ultrasonic heat seal technology.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 defeat 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 thermal seal, critical to the functionality and longevity of the thermacare care product.The root cause for never worked, too cool did not long enough and squeeze tube complaint sub classless is due to a pouch (primary packing) that did not seal completely (open pouch).An open pouch will expose the wrap to air before the consumer; specifically ultrasonic technology.The corrective action is to purchase and install three (3) new heat seal flow wrapper machines in both production lines.Capa is in-place to replace the ultrasonic sealers with heat seal technology.Device history record (dhr) is not reviewed for an unknown batch number.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, 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 primary container damage and defect not classified.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.Reasonably suggest device malfunction: yes.Severity of harm: s1.Site sample status: not received.On 28sep2020, the product quality complaint group provided the following investigation results that yielded no product quality issues.Product: thermacare lower back & hip.Lot number and expiration date: dk2631 and jan2023.Description of compliant: "sometimes use the back pain wraps on her wrists, for her tendinitis if that's all she has".Complaint sub-class: adverse event/negligible-minor.Reasonably suggest device malfunction: no.Severity of harm: n/a.Site sample status: not received.Summary of investigation: batch dk2631 is the only batch within the scope of this investigation.Thermacare batches are produced as individual lots.The device history record (dhr), reserve samples, and trending were evaluated.No quality issues were identified.Root cause/capa: process related: no; final confirmation status: not confirmed; root cause category: non-assignable (complaint not confirmed).Conclusion: the root cause category is non assignable (complaint not confirmed as a quality defect).After a review of the batch thermal records, thermal results all met product release criteria.Consumer reports "sometimes use the back pain wraps on her wrists, for her tendinitis if that's all she has." the reviewof records does not provide evidence to support defective products.The complaint can not be confirmed.The product effect may vary with each individual.Care should be taken when using the device, following all safety and use information as provided with the wrap to avoid any health risk.The plant has reviewed this batch from a manufacturing perspective.No quality issues were identified upon this review of batch records, release testing data or, an inspection of retained samples.Retained samples met the product description, and the product is within the expiration date.This complaint does not impact the product quality for the batch.No follow-up attempts are needed.No further information is expected.Follow-up (08sep2020), (08sep2020) and (08sep2020): additional information received from the same contactable nurse (reporting for herself) included: reporter (lpn), product complaint( found two more boxes of thermacare heat wraps popped open, exposed to air, almost all the bags were ruptured.), product usage details (wears one wrap in the day and a second wrap at night).Follow-up (11sep2020) and (14sep2020): new information received from product quality complaint group included: investigation results.No follow-up attempts are needed.No further information is expected.Follow-up (16sep2020): this is a follow-up report received from a contactable nurse (reporting for herself).New information included device information.Tendinitis was added as additional indication.Patient's age was updated.No follow-up attempts are needed.No further information is expected.Follow-up (28sep2020): new information received from the product quality complaint group included: investigation results that yielded no product quality issues.No follow-up attempts are needed.No further information is expected.

Manufacturer Narrative

Event Description

Event verbatim [preferred term] , use the back pain wraps on her wrists [device use issue], cut it and wrap it around and it works well for her/wears one wrap in the day and a second wrap at night [intentional device misuse], the individual packs are popped open and exposed to air/has 8 boxes of thermacare that were already activated because the wrapper wasn't completely sealed/almost all the bags were ruptured [device issue], , narrative: this is a spontaneous report from a contactable health care professional licensed practical nurse (lpn) reporting for herself.A female patient of an unspecified age (currently 72-year-old) started to receive thermacare heatwrap (thermacare lower back & hip) 'back pain therapy, l-xl' 1 box with device lot number dk2631, expiration date jan2023 and 2 boxes with lot number: de4866, expiration date: dec2022, upc code was the same on all 3 boxes, used on her back from an unspecified date to an unspecified date for back pain, and on her wrist from an unspecified date to an unspecified date for tendinitis.The patient medical history and concomitant medications were not reported.The patient reported a few years back, she had gotten a couple that were not sealed so wrap didn't work; didn't heat up.She never checked the boxes or the wrappers, she would just put it on and then go to work and would notice that it wasn't heating up.She found out by accident that one wrapper was opened about 1/2 inch on one side, so now she started checking the boxes.She always checked the packages to make sure the seals were correct.The patient stated that to better describe it, on the edges of each package, it showed the scissor cut, that was where it was opened about an inch on the packages; one of them was opened almost all the way; it was like the machine didn't come down to seal it.The consumer reported she wore one wrap in the day and a second wrap at night and had worn them like this for years.She purchased 12 boxes this week (usually buys 12 boxes per week), she had 3 boxes, with 2 wraps in each box, and all 6 wraps the seal was not completely sealed so the wraps were no good.She stated she had kept 1 wrap from each box.When she put one on she depended on it to work.Sometimes used the back pain wraps on her wrists for her tendinitis; if that was all she had.She would just cut it and wrap it around and it worked well for her.Consumer stated that she did receive the mailer but since her last call to pfizer, she found two more boxes of thermacare heatwraps with the same problem.Almost all the bags were ruptured.She had 8 boxes of thermacare that were already activated because the wrapper wasn't completely sealed.The individual packs were popped open and exposed to air.Consumer did not use them because when they were exposed to air they were hard and non-usable.She put the new ones that were popped open in with the original product complaint wraps to send back to pfizer.The box was discarded and doesn't know the upc, lot or expiration date for the additional product.She had everything set up to send back and has requested a refund.The action taken with thermacare heatwrap was unknown.The clinical outcome of the event was unknown.Packaging was sealed and intact for the boxes, but no for the wrappers.The patient had already sent the products back, 8 packages, that had split.They did not seal properly.She put them all in the box and sent the boxes.On 11sep2020, according to the product quality control group :in 2013 a complaint trend was opened for the pouch seal defect.The trend directly correlates with the implementation of ultrasonic heat seal technology.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 defeat 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 thermal seal, critical to the functionality and longevity of the thermacare care product.The root cause for never worked, too cool did not long enough and squeeze tube complaint sub classless is due to a pouch (primary packing) that did not seal completely (open pouch).An open pouch will expose the wrap to air before the consumer; specifically ultrasonic technology.The corrective action is to purchase and install three (3) new heat seal flow wrapper machines in both production lines.Capa is in-place to replace the ultrasonic sealers with heat seal technology.Device history record (dhr) is not reviewed for an unknown batch number.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, 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 primary container damage and defect not classified.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.Reasonably suggest device malfunction: yes.Severity of harm: s1.Site sample status: not received.On 28sep2020, the product quality complaint group provided the following investigation results that yielded no product quality issues.Product: thermacare lower back & hip.Lot number and expiration date: dk2631 and jan2023.Description of compliant: "sometimes use the back pain wraps on her wrists, for her tendinitis if that's all she has".Complaint sub-class: adverse event/negligible-minor.Reasonably suggest device malfunction: no.Severity of harm: n/a.Site sample status: not received.Summary of investigation: batch (b)(6) is the only batch within the scope of this investigation.Thermacare batches are produced as individual lots.The device history record (dhr), reserve samples, and trending were evaluated.No quality issues were identified.Root cause/capa: process related: no; final confirmation status: not confirmed; root cause category: non-assignable (complaint not confirmed).Conclusion: the root cause category is non assignable (complaint not confirmed as a quality defect).After a review of the batch thermal records, thermal results all met product release criteria.Consumer reports "sometimes use the back pain wraps on her wrists, for her tendinitis if that's all she has." the review of records does not provide evidence to support defective products.The complaint can not be confirmed.The product effect may vary with each individual.Care should be taken when using the device, following all safety and use information as provided with the wrap to avoid any health risk.The plant has reviewed this batch from a manufacturing perspective.No quality issues were identified upon this review of batch records, release testing data or, an inspection of retained samples.Retained samples met the product description, and the product is within the expiration date.This complaint does not impact the product quality for the batch.According to the product quality complaint group on 09oct2020: product: thermacare lower back & hip.Lot number: de4866, expiration date: dec2022.Summary of investigation: batch code#: de4866; date of manufacture: 02jan2020 to 10jan2020; de4866 is the only batch within the scope of this investigation.Thermacare batches are produced as individual lots.The device history record (dhr), reserve samples, and trending were evaluated.No quality issues were identified.Conclusion: the root cause category is non assignable (complaint not confirmed as a quality defect).After a review of the batch thermal records, thermal results all met product release criteria.Consumer reported "used on her back from an unspecified date to an unspecified date for back pain, and on her wrist." review of records does not provide evidence to support defective product.Care should be taken when using the device, following all safety and use information as provided with the wrap to avoid any health risk.The plant has reviewed this batch from a manufacturing perspective.No quality issues were identified upon this review of batch records, release testing data or, inspection of retained samples.Retained samples met the product description and the product is within expiration date.The product quality for the batch is not impacted by this complaint.Lot trend assmt.& rationale: an evaluation of the complaint history confirms that this is the second complaint for the sub class adverse event/negligible-minor received at the (site name) site requiring an evaluation for this lot.Per #, complaint trending guideline, effective 24feb2020, a visual evaluation was performed to identify a potential trend for the lot and subclass.A trend was not identified.On this basis, a trend does not exist for this batch.Site sample status was not received.No follow-up attempts are needed.No further information is expected.Follow-up (08sep2020, 08sep2020 and 08sep2020): additional information received from the same contactable nurse (reporting for herself) included: reporter (lpn), product complaint( found two more boxes of thermacare heat wraps popped open, exposed to air, almost all the bags were ruptured.), product usage details (wears one wrap in the day and a second wrap at night).Follow-up (11sep2020 and 14sep2020): new information received from product quality complaint group included: investigation results.No follow-up attempts are needed.No further information is expected.Follow-up (16sep2020): new information reported from a contactable nurse (reporting for herself) included device information.Tendinitis was added as additional indication.Patient's age was updated.No follow-up attempts are needed.No further information is expected.Follow-up (28sep2020): new information received from the product quality complaint group included: investigation results that yielded no product quality issues.No follow-up attempts are needed.No further information is expected.Follow-up (09oct2020): new information received from the product quality complaint group included investigational results for lot number de4866.Case amended to update operator of device to health professional.No follow up attempts are needed.No further information is expected.

Manufacturer Narrative

Search Alerts/Recalls

New Search | Submit an Adverse Event Report

Brand Name

THERMACARE LOWER BACK & HIP

Type of Device

DISPOSABLE PACK, HOT

Manufacturer (Section D)

PFIZER CONSUMER HEALTH CARE

1231 wyandotte drive

albany GA 31705

MDR Report Key

10537875

MDR Text Key

212733187

Report Number

1066015-2020-00164

Device Sequence Number

Product Code

IMD

Combination Product (y/n)

PMA/PMN Number

K953442

Number of Events Reported

Summary Report (Y/N)

Report Source

Manufacturer

Source Type

health professional

Type of Report

Initial,Followup,Followup,Followup,Followup

Report Date

09/01/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

Is this an Adverse Event Report?

Yes

Is this a Product Problem Report?

Yes

Device Operator

Health Professional

Device Expiration Date

12/01/2022

Device Lot Number

DE4866;DK2631

Was Device Available for Evaluation?

Device Returned to Manufacturer

Date Returned to Manufacturer

09/09/2020

Initial Date Manufacturer Received

Not provided

Initial Date FDA Received

09/15/2020

Supplement Dates Manufacturer Received

Not provided
Not provided
Not provided
Not provided
Not provided
Not provided

Supplement Dates FDA Received

09/25/2020
10/02/2020
10/14/2020
10/15/2020
12/01/2020
12/07/2020

Is This a Reprocessed and Reused Single-Use Device?

Patient Sequence Number

Patient Age

72 YR

Patient Weight

MAUDE Adverse Event Report: PFIZER CONSUMER HEALTH CARE THERMACARE LOWER BACK & HIP; DISPOSABLE PACK, HOT

Links on this page:

Links on this page: