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

Lot Number AA2376

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Scarring (2061); Burn, Thermal (2530)

Event Type  Injury  

Event Description

Burnt her husband's skin [thermal burn] , the product left a scar on her husband [scar] ,.Case narrative:this is a spontaneous report from a contactable consumer (patient's wife).A patient of unknown age and gender started to receive thermacare heatwrap (thermacare lower back & hip) batch number: aa2376, 1218711, expiry date: nov2021 from an unspecified date for an unspecified indication.The patient medical history and concomitant medications were not reported.On an unspecified date, the consumer reported the product left a scar on her husband.They bought it in october and used it.The product burnt her husband's skin and they went to the doctor.It was reported that this event happened months prior to the report, although the scar was still visible.The product was bought from (b)(6).The customer wanted a refund for the product since it left a scar on her husband's skin.The action taken in response to the events for thermacare heatwrap and the outcome of the event was unknown.Additional information has been requested and will be provided as it becomes available.Company clinical evaluation comment: based on the information provided, the complaints of "burnt her husband's skin and left a scar" as described are considered serious bodily injury potentially requiring medical intervention to prevent permanent damage or impairment of body structure.A causal relationship between the device and the complaints cannot be ruled out., comment: based on the information provided, the complaints of "burnt her husband's skin and left a scar" as described are considered serious bodily injury potentially requiring medical intervention to prevent permanent damage or impairment of body structure.A causal relationship between the device and the complaints cannot be ruled out.

Event Description

Event verbatim [preferred term].Burnt her husband's skin [thermal burn], the product left a scar on her husband [scar].Narrative: this is a spontaneous report from a contactable consumer (patient's wife).A patient of unknown age and gender started to receive thermacare heatwrap (thermacare lower back & hip) batch number: aa2376, expiry date: nov2021 from an unspecified date for an unspecified indication.The patient medical history and concomitant medications were not reported.On an unspecified date, the consumer reported the product left a scar on her husband.They bought it in october and used it.The product burnt her husband's skin and they went to the doctor.It was reported that this event happened months prior to the report, although the scar was still visible.The product was bought from amazon uk.The customer wanted a refund for the product since it left a scar on her husband's skin.The action taken in response to the events for thermacare heatwrap was unknown.The outcome of 'burnt her husband's skin' was unknown.The outcome of 'the product left a scar on her husband' was not resolved.According to product quality complaint group: summary of investigation: batch aa2376, is the only batch within the scope of this investigation.Thermacare batches are produced as individual lots.The device history report (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 the wrap "burnt" and "left a scar".The cause of the consumer stating the wrap caused a burn and left a scar is inconclusive since review of records does not provide evidence to support defective product.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, thermal 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.Exped trend actions taken: based on this citi search, there is not a trend identified for the subclass of adverse event/serious/unknown, adverse event safety request for investigation and adverse event negligible-minor.Reasonably suggest device malfunction was yes.Severity of harm was s3.The sample had not been received by the site.Follow-up (16apr2020): new information received from product quality complaint group included: investigation result and severity rating., comment: based on the information provided, the complaints of "burnt her husband's skin and left a scar" as described are considered serious bodily injury potentially requiring medical intervention to prevent permanent damage or impairment of body structure.A causal relationship between the device and the complaints cannot be ruled out.The review of the lot/batch records does not suggest a defect or quality issue related to the manufacture of this lot.No device malfunction has been identified.No remedial action/corrective action/field safety corrective action is suggested at this time.

Manufacturer Narrative

Summary of investigation: batch aa2376, is the only batch within the scope of this investigation.Thermacare batches are produced as individual lots.The device history report (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 the wrap "burnt" and "left a scar".The cause of the consumer stating the wrap caused a burn and left a scar is inconclusive since review of records does not provide evidence to support defective product.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, thermal 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.Exped trend actions taken: based on this citi search, there is not a trend identified for the subclass of adverse event/serious/unknown, adverse event safety request for investigation and adverse event negligible-minor.Reasonably suggest device malfunction was yes.Severity of harm was s3.The sample had not been received by the site.

Manufacturer Narrative

Summary of investigation: batch aa2376 is the only batch within the scope of this investigation.Thermacare batches are produced as individual lots.The device history report (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 the wrap "burnt" and "left a scar".The cause of the consumer stating the wrap caused a burn and left a scar is inconclusive since review of records does not provide evidence to support defective product.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, thermal 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.Reasonably suggest device malfunction was yes.Severity of harm was s3.The sample had not been received by the site.Lot trend assmt.& rationale: an evaluation of the complaint confirms that this is the second complaint for the sub class adverse event/serious/unknown received at the albany site requiring an evaluation for this batch.The previous complaint was not confirmed to have a manufacturing root cause related to the subclass.Per sop-105746, complaint trending guideline, effective (b)(6) 2020, a visual examination was performed to identify a potential trend for the subclass and lot.A trend was not identified.On the basis of this evaluation, a trend does not exist for this lot.Exped trend actions taken: based on this citi search, there is not a trend identified for the subclass of adverse event/serious/unknown, adverse event safety request for investigation and adverse event negligible-minor.There was deviation from sop-105746, complaint trending guidelines, effective (b)(6) 2020 in which the expedite trending of complaint investigations was trended for a 24-month period instead of a 36-month period.This investigation was reopened to correct the trending.The results do not change the root cause of the complaint.Corrections will be completed in pr-5283155, action item pr-5283193.

Event Description

Event verbatim [preferred term].Burnt her husband's skin [thermal burn], the product left a scar on her husband [scar], , narrative: this is a spontaneous report from a contactable consumer (patient's wife).A patient of unknown age and gender started to receive thermacare heatwrap (thermacare lower back & hip), lot number: aa2376, expiry date: nov2021, from an unspecified date for an unspecified indication.The patient medical history and concomitant medications were not reported.On an unspecified date, the consumer reported the product left a scar on her husband.They bought it in (b)(6) and used it.The product burnt her husband's skin and they went to the doctor.It was reported that this event happened months prior to the report, although the scar was still visible.The product was bought from amazon uk.The customer wanted a refund for the product since it left a scar on her husband's skin.The action taken in response to the events for thermacare heatwrap was unknown.The outcome of 'burnt her husband's skin' was unknown.The outcome of 'the product left a scar on her husband' was not resolved.According to product quality complaint group: summary of investigation: batch aa2376 is the only batch within the scope of this investigation.Thermacare batches are produced as individual lots.The device history report (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 the wrap "burnt" and "left a scar".The cause of the consumer stating the wrap caused a burn and left a scar is inconclusive since review of records does not provide evidence to support defective product.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, thermal 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.Reasonably suggest device malfunction was yes.Severity of harm was s3.The sample had not been received by the site.Lot trend assmt.& rationale: an evaluation of the complaint confirms that this is the second complaint for the sub class adverse event/serious/unknown received at the albany site requiring an evaluation for this batch.The previous complaint was not confirmed to have a manufacturing root cause related to the subclass.Per sop-105746, complaint trending guideline, effective (b)(6) 2020, a visual examination was performed to identify a potential trend for the subclass and lot.A trend was not identified.On the basis of this evaluation, a trend does not exist for this lot.Exped trend actions taken: based on this citi search, there is not a trend identified for the subclass of adverse event/serious/unknown, adverse event safety request for investigation and adverse event negligible-minor.There was deviation from sop-105746, complaint trending guidelines, effective (b)(6) 2020 in which the expedite trending of complaint investigations was trended for a 24-month period instead of a 36-month period.This investigation was reopened to correct the trending.The results do not change the root cause of the complaint.Corrections will be completed in pr-5283155, action item pr-5283193.Follow-up (16apr2020): new information received from product quality complaint group included: investigation result and severity rating.Follow-up (06may2020): follow-up attempts completed.No further information expected.Follow-up (13oct2020): new information received from product quality complaint group included: updated trending information.No follow up attempts are possible.No further information is expected., comment: based on the information provided, the complaints of "burnt her husband's skin and left a scar" as described are considered serious bodily injury potentially requiring medical intervention to prevent permanent damage or impairment of body structure.A causal relationship between the device and the complaints cannot be ruled out.The review of the lot/batch records does not suggest a defect or quality issue related to the manufacture of this lot.No device malfunction has been identified.No remedial action/corrective action/field safety corrective action is suggested at this time.

• 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: 9847800
• MDR Text Key: 189450884
• Report Number: 1066015-2020-00076
• 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,foreign
• Type of Report: Initial,Followup,Followup
• Report Date: 03/05/2020

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: 11/01/2021
• Device Lot Number: AA2376
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 03/18/2020
• Supplement Dates Manufacturer Received: Not provided; Not provided
• Supplement Dates FDA Received: 04/23/2020; 10/19/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention