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

Lot Number DK2629

Device Problems Adverse Event Without Identified Device or Use Problem (2993); Excessive Heating (4030)

Patient Problem Burn, Thermal (2530)

Event Date 10/21/2020

Event Type  Injury  

Event Description

Burnt her side [thermal burn], , narrative: this is a spontaneous report from a contactable consumer or other non healthcare professional.A (b)(6) year-old female patient started to use thermacare heatwrap (thermacare lower back & hip) from an unspecified date for pain in her side.The patient's medical history and concomitant medications were not reported.The patient purchased the product on (b)(6) 2020 and had never previously used the product.On the morning of (b)(6) 2020, she applied the product and before knowing it, she looked at it and the skin was burnt.She stated she had the wrap on for no more than 4 hours and it burnt her side.The box that the one that burnt her came out of she doesn't have anymore because she threw it in the garbage can.The packaging was sealed and intact.Action taken with the suspect product was permanently withdrawn on an unspecified date in 2020.Therapeutic measures taken included cocoa butter on the burn.Clinical outcome of the event was unknown.Additional information has been requested and will be provided as it becomes available.

Event Description

Event verbatim [preferred term] burnt her side [thermal burn], , narrative: this is a spontaneous report from a contactable consumer or other non healthcare professional.A 51-year-old female patient started to use thermacare heatwrap (thermacare lower back & hip) from an unspecified date for pain in her side.The patient's medical history and concomitant medications were not reported.The patient purchased the product on (b)(6) 2020 and had never previously used the product.On the morning of (b)(6) 2020, she applied the product and before knowing it, she looked at it and the skin was burnt.She stated she had the wrap on for no more than 4 hours and it burnt her side.The box that the one that burnt her came out of she doesn't have anymore because she threw it in the garbage can.The packaging was sealed and intact.Action taken with the suspect product was permanently withdrawn on an unspecified date in (b)(6) 2020.Therapeutic measures taken included cocoa butter on the burn.Clinical outcome of the event was unknown.Additional information has been requested and will be provided as it becomes available.Amendment: this follow-up report is being submitted to amend previously reported information: updated patient age from 50 to 51 years old.

Event Description

Event verbatim [preferred term].Burnt her side [thermal burn], narrative: this is a spontaneous report from a contactable consumer.A 51-year-old female patient started to use thermacare heatwrap (thermacare lower back & hip), lot number: dk2629, expiry date: jan2023, from 21oct2020 for pain in her side.The patient's medical history and concomitant medications were not reported.The patient purchased the product on (b)(6) 2020 and had never previously used the product.On the morning of (b)(6) 2020, she applied the product and before knowing it, she looked at it and the skin was burnt.She stated she had the wrap on for no more than 4 hours and it burnt her side.She further reported the last time she called she didn't have the box but she had two other boxes that had never been used.The patient did not have the box with the patch that burned her as she had discarded it, no ndc, udi, lot or expiration date known.She bought three boxes of thermacare back pain therapy from the same store.Provides the lot number dk2629 from the remaining two unopened boxes as both of these boxes had the same lot.The box that the one that burnt her came out of she didn't have anymore because she threw it in the garbage can.The packaging was sealed and intact.Action taken with the suspect product was permanently withdrawn on an unspecified date in (b)(6) 2020.Therapeutic measures taken included cocoa butter on the burn.Clinical outcome of the event was unknown.According to product quality complaint: date of manufacture: 26feb2020 to 27feb2020.Batch dk2629 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 reports " it burnt her side." the cause of the consumer statement "it burnt her side" is inconclusive since review of records does not provide evidence to support defective product.The product effect may vary with each individual.Care should be taken when using the device.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 first complaint for the sub class adverse event/negligible-minor received at the (site name) site requiring an evaluation for this batch.On the basis of this evaluation, a trend does not exist for this batch.An evaluation was made by searching for possible trends for this subclass requiring investigation by the site.Based on this citi search, no trend identified for the subclass adverse event negligible-minor for lbh 8hr products.Process related was no.Final confirmation status was not confirmed.Site sample status was received at the site on 03nov2020.Return sample evaluation: 1 carton - (l) dk2629 - carton is open.1 wrap - wrap shows no evidence of wear.No obvious defects.Amendment: this follow-up report is being submitted to amend previously reported information: updated patient age from 50 to 51 years old.Follow-up (19nov2020) : new information received from product quality complaint includes investigation results, suspect product data (lot number, expiry date), device problem code updated.

Manufacturer Narrative

Batch dk2629 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 reports " it burnt her side." the cause of the consumer statement "it burnt her side" is inconclusive since review of records does not provide evidence to support defective product.The product effect may vary with each individual.Care should be taken when using the device.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 first complaint for the sub class adverse event/negligible-minor received at the (site name) site requiring an evaluation for this batch.On the basis of this evaluation, a trend does not exist for this batch.An evaluation was made by searching for possible trends for this subclass requiring investigation by the site.Based on this citi search, no trend identified for the subclass adverse event negligible-minor for lbh 8hr products.Process related was no.Final confirmation status was not confirmed.Site sample status was received at the site.Return sample evaluation: 1 carton - (l) dk2629 - carton is open.1 wrap - wrap shows no evidence of wear.No obvious defects.

Manufacturer Narrative

Batch dk2629 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 reports " it burnt her side." the cause of the consumer statement "it burnt her side" is inconclusive since review of records does not provide evidence to support defective product.The product effect may vary with each individual.Care should be taken when using the device.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 first complaint for the sub class adverse event/negligible-minor received at the (site name) site requiring an evaluation for this batch.On the basis of this evaluation, a trend does not exist for this batch.An evaluation was made by searching for possible trends for this subclass requiring investigation by the site.Based on this citi search, no trend identified for the subclass adverse event negligible-minor for lbh 8hr products.Process related was no.Final confirmation status was not confirmed.Site sample status was received at the site.Return sample evaluation: 1 carton - (l) dk2629 - carton is open.1 wrap - wrap shows no evidence of wear.No obvious defects.Additional information provided by pqc on 12feb2021: there was reasonable suggestion of device malfunction, with severity of harm: s3.Summary of investigation: based on the complaint narrative, the patient stated she had the wrap on for no more than 4 hours and it burnt her side.Batch dk2629 is the only batch within the scope of this investigation.Thermacare batches are produced as individual lots.Review of the batch device history record for this batch concludes all release requirements were met.The review of the manufacturing attributes and variables quality checks associated with this batch indicates that all required in process inspections were performed and all inspection criteria were met.There were no wrap attribute or variable defects recorded for the batch.Thermal data for the batch shows all wraps met the required wrap batch average temperatures(37.6°c - 41.6°c) per thermacare / lower back and hip, unprinted spec-#; effective date: 03dec2019.This batch has been reviewed from a manufacturing perspective.There are no known site investigations associated with thisbatch involving wrap temperatures.The visual inspection of a retain sample included one carton and the 2 pouched wraps inside and shows no obvious defects.Additional conclusion: the complaint sample was received and no obvious defects were found.The complaint sample was not confirmed.

Event Description

Event verbatim [preferred term] burnt her side [thermal burn], , narrative: this is a spontaneous report from a contactable consumer.A 51-year-old female patient started to use thermacare heatwrap (thermacare lower back & hip), lot number: dk2629, expiry date: jan2023, from (b)(6) 2020 for pain in her side.The patient's medical history and concomitant medications were not reported.The patient purchased the product on (b)(6) 2020 and had never previously used the product.On the morning of (b)(6) 2020, she applied the product and before knowing it, she looked at it and the skin was burnt.She stated she had the wrap on for no more than 4 hours and it burnt her side.She further reported the last time she called she didn't have the box but she had two other boxes that had never been used.The patient did not have the box with the patch that burned her as she had discarded it, no ndc, udi, lot or expiration date known.She bought three boxes of thermacare back pain therapy from the same store.Provides the lot number dk2629 from the remaining two unopened boxes as both of these boxes had the same lot.The box that the one that burnt her came out of she didn't have anymore because she threw it in the garbage can.The packaging was sealed and intact.Action taken with the suspect product was permanently withdrawn on an unspecified date in (b)(6) 2020.Therapeutic measures taken included cocoa butter on the burn.Clinical outcome of the event was unknown.According to product quality complaints (pqc): date of manufacture: 26feb2020 to 27feb2020.Batch dk2629 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 reports " it burnt her side." the cause of the consumer statement "it burnt her side" is inconclusive since review of records does not provide evidence to support defective product.The product effect may vary with each individual.Care should be taken when using the device.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 first complaint for the sub class adverse event/negligible-minor received at the (site name) site requiring an evaluation for this batch.On the basis of this evaluation, a trend does not exist for this batch.An evaluation was made by searching for possible trends for this subclass requiring investigation by the site.Based on this citi search, no trend identified for the subclass adverse event negligible-minor for lbh 8hr products.Process related was no.Final confirmation status was not confirmed.Site sample status was received at the site on 03nov2020.Return sample evaluation: 1 carton - (l) dk2629 - carton is open.1 wrap - wrap shows no evidence of wear.No obvious defects.Additional information provided by pqc on 12feb2021: there was reasonable suggestion of device malfunction, with severity of harm: s3.Summary of investigation: based on the complaint narrative, the patient stated she had the wrap on for no more than 4 hours and it burnt her side.Batch dk2629 is the only batch within the scope of this investigation.Thermacare batches are produced as individual lots.Review of the batch device history record for this batch concludes all release requirements were met.The review of the manufacturing attributes and variables quality checks associated with this batch indicates that all required in process inspections were performed and all inspection criteria were met.There were no wrap attribute or variable defects recorded for the batch.Thermal data for the batch shows all wraps met the required wrap batch average temperatures(37.6°c - 41.6°c) per thermacare / lower back and hip, unprinted spec-#; effective date: 03dec2019.This batch has been reviewed from a manufacturing perspective.There are no known site investigations associated with thisbatch involving wrap temperatures.The visual inspection of a retain sample included one carton and the 2 pouched wraps inside and shows no obvious defects.Additional conclusion: the complaint sample was received and no obvious defects were found.The complaint sample was not confirmed.Amendment: this follow-up report is being submitted to amend previously reported information: updated patient age from 50 to 51 years old.Follow-up (19nov2020): new information received from product quality complaint includes investigation results, suspect product data (lot number, expiry date), device problem code updated.Follow-up (24nov2020): follow-up attempts completed.No further information expected.Follow -up (12feb2021): new information from product quality complaints included: additional investigation results.Follow-up attempts completed.No further information expected.

• 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: 10763447
• MDR Text Key: 213937107
• Report Number: 1066015-2020-00184
• Device Sequence Number: 1
• Product Code: IMD
• Combination Product (y/n): N
• PMA/PMN Number: K953442
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 10/21/2020

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: Lay User/Patient
• Device Expiration Date: 01/01/2023
• Device Lot Number: DK2629
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/03/2020
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 10/30/2020
• Supplement Dates Manufacturer Received: Not provided; Not provided; Not provided
• Supplement Dates FDA Received: 11/12/2020; 11/24/2020; 03/02/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 51 YR
• Patient Weight: 84