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

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

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

Event Type  Injury  

Event Description

Burn with permanent scar from one of the cells [thermal burn], a burn with permanent scar from one of the cells [scar].Case narrative: this is a spontaneous report from a contactable consumer.A patient of unspecified age and gender started to receive thermacare heatwrap (thermacare lower back & hip), from an unspecified date, for an unspecified indication.Medical history included numerous ailments: migraines, cervical dystonia, hypermobile ethlers danlos, autonomic dysfunction, sjogren's, triple cervical fusion, and misc joint pain.Concomitant medications were not reported.The patient reported that she uses the heat wraps all the time.She suffers from numerous ailments and the product gives her some relief.She did suffer a burn with permanent scar from one of the cells but "they help so much i continue to use".The action taken with thermacare heatwrap was not reported.The outcome of the permanent scar was not recovered, for the burn was unknown.Company clinical evaluation comment: based on the information provided, the events of "burn with permanent scar from one of the cells" as described are considered serious bodily injury requiring medical intervention to prevent permanent damage or impairment of body structure.A causal relationship between the device and the events cannot be ruled out.Comment: based on the information provided, the events of "burn with permanent scar from one of the cells" as described are considered serious bodily injury requiring medical intervention to prevent permanent damage or impairment of body structure.A causal relationship between the device and the events cannot be ruled out.

Event Description

Event verbatim [preferred term] a burn with permanent scar from one of the cells [thermal burn] , a burn with permanent scar from one of the cells [scar] ,.Case narrative:this is a spontaneous report from a contactable consumer.A patient of unspecified age and gender started to receive thermacare heatwrap (thermacare lower back & hip), from an unspecified date, for an unspecified indication.Medical history included numerous ailments: migraines, cervical dystonia, hypermobile ehlers-danlos syndrome, autonomic dysfunction, sjogren's, triple cervical fusion, and misc joint pain.Concomitant medications were not reported.The patient reported that she uses the heat wraps all the time.She suffers from numerous ailments and the product gives her some relief.She did suffer a burn with permanent scar from one of the cells but "they help so much i continue to use".The action taken with thermacare heatwrap was not reported.The outcome of the permanent scar was not recovered, for the burn was unknown.Product quality complaints provided the following: a return sample has not been received at the site for evaluation as of 08jan2020.Final confirmation status was not confirmed.This investigation was conducted for an unknown lot number of lower back/hip (lbh) product.The root cause category is non-assignable (complaint not confirmed as a quality defect).There was limited device specific information provided, no batch number or return sample was available for evaluation.Without a batch reference number and/or return sample a manufacturing and technical evaluation cannot be completed for the wrap involved in this case.There is not a product quality related trend identified for the subclass adverse event safety/serious/unknown.The manufacturing operations employ quality control procedures which include in process testing, thermal testing and visual inspection, to ensure the quality of the product being packaged.Follow-up (22jan2020): new information report from product quality complaints includes: investigation results.Company clinical evaluation comment: based on the information provided, the events of "burn with permanent scar from one of the cells" as described are considered serious bodily injury requiring medical intervention to prevent permanent damage or impairment of body structure.A causal relationship between the device and the events cannot be ruled out.There was limited device specific information provided, no batch number or return sample was available for evaluation.Without a batch reference number and/or return sample a manufacturing and technical evaluation cannot be completed for the wrap involved in this case.Product effect varies with each individual.There is not a product quality related trend identified.No further investigations or actions is suggested at this time., comment: based on the information provided, the events of "burn with permanent scar from one of the cells" as described are considered serious bodily injury requiring medical intervention to prevent permanent damage or impairment of body structure.A causal relationship between the device and the events cannot be ruled out.There was limited device specific information provided, no batch number or return sample was available for evaluation.Without a batch reference number and/or return sample a manufacturing and technical evaluation cannot be completed for the wrap involved in this case.Product effect varies with each individual.There is not a product quality related trend identified.No further investigations or actions is suggested at this time.

Manufacturer Narrative

A return sample has not been received at the site for evaluation as of 08jan2020.Final confirmation status was not confirmed.This investigation was conducted for an unknown lot number of lower back/hip (lbh) product.The root cause category is non-assignable (complaint not confirmed as a quality defect).There was limited device specific information provided, no batch number or return sample was available for evaluation.Without a batch reference number and/or return sample a manufacturing and technical evaluation cannot be completed for the wrap involved in this case.There is not a product quality related trend identified for the subclass adverse event safety/serious/unknown.The manufacturing operations employ quality control procedures which include in process testing, thermal testing and visual inspection, to ensure the quality of the product being packaged.

• 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: 9576331
• MDR Text Key: 189162689
• Report Number: 1066015-2020-00003
• 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
• Report Date: 01/01/2020

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: Lay User/Patient
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 01/10/2020
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 02/07/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention