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

Lot Number T48943

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

Patient Problems Skin Discoloration (2074); Caustic/Chemical Burns (2549); No Code Available (3191)

Event Date 10/22/2018

Event Type  Injury  

Event Description

A bad chemical burn [chemical burn], little open wounds [wound], dark discoloration on my back has not gone away [skin discolouration].Case narrative: this is a spontaneous report from a contactable consumer (patient).This is a report received from the us fda.Regulatory authority report number is mw5082768.A patient of unspecified age and gender started to receive thermacare heatwrap (thermacare lower back & hip), device lot number t48943, expiration date 31oct2020, from an unspecified date for less than 5 hrs for back stiffness and pain.The patient medical history and concomitant medications were not reported.The patient stated, "i had back stiffness and pain, so i went to (b)(6) and purchased thermacare advanced back pain therapy, which i had used before.Read instructions and put it on at work.Left work early and took it off when i got home so it was less than 5 hrs.The next day ((b)(6) 2018) noticed a dark huge mark on my back which had little open wounds to it.I went to my doctor who let me know it was a bad chemical burn and prescribed me ascend antibiotic medicine which healed the open wounds, however the dark discoloration on my back has not gone away and doctor said it may be permanent.This is horrible." the action taken for the product was stopped.The problem did not stop after the patient stopping taking or using the product.The outcome of event open wounds was recovered.The outcome of the event a bad chemical burn and the dark discoloration on my back was not recovered.The device was available for evaluation.The event report type was serious injury.The event outcome was other serious (important medical event).Sus voluntary event report (foi for manufacturers): this output contains the medical device adverse event reports currently available to the public, in accordance with the freedom of information act and the requested search criteria.No follow-up attempts are possible.No further information is expected.

Manufacturer Narrative

Investigation summary: 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 caused a "huge dark mark" to appear on her back which had "little open wounds" after use.The cause of the wrap causing burns 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, following all safety and use information as provided with the wrap to avoid the risks of burns or other skin irritations.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.

Event Description

Event verbatim [preferred term] a bad chemical burn [chemical burn] , little open wounds [wound] , dark discoloration on my back has not gone away [skin discolouration] ,.Case narrative:this is a spontaneous report from a contactable consumer (patient).This is a report received from the us fda.Regulatory authority report number is mw5082768.A patient of unspecified age and gender started to receive thermacare heatwrap (thermacare lower back & hip), device lot number t48943, expiration date 31oct2020, from an unspecified date for less than 5 hrs for back stiffness and pain.The patient medical history and concomitant medications were not reported.The patient stated, "i had back stiffness and pain, so i went to (b)(6) and purchased thermacare advanced back pain therapy, which i had used before.Read instructions and put it on at work.Left work early and took it off when i got home so it was less than 5 hrs.The next day ((b)(6) 2018) noticed a dark huge mark on my back which had little open wounds to it.I went to my doctor who let me know it was a bad chemical burn and prescribed me ascend antibiotic medicine which healed the open wounds, however the dark discoloration on my back has not gone away and doctor said it may be permanent.This is horrible." the action taken for the product was stopped.The problem did not stop after the patient stopping taking or using the product.The outcome of event open wounds was recovered.The outcome of the event a bad chemical burn and the dark discoloration on my back was not recovered.The device was available for evaluation.The event report type was serious injury.The event outcome was other serious (important medical event).Sus voluntary event report (foi for manufacturers).This output contains the medical device adverse event reports currently available to the public, in accordance with the freedom of information act and the requested search criteria.Submission of a report does not constitute an admission that medical personal, user facility, importer, manufacturer or product caused or contributed to the event.According to the product quality complaint group: investigation summary: 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 caused a "huge dark mark" to appear on her back which had "little open wounds" after use.The cause of the wrap causing burns 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, following all safety and use information as provided with the wrap to avoid the risks of burns or other skin irritations.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.No follow-up attempts are possible.No further information is expected.Follow-up (14mar2019): new information received from product quality complaint group includes investigation results.No follow-up attempts are possible.No further information is 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: 8332187
• MDR Text Key: 136241094
• Report Number: 1066015-2019-00035
• 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: 01/31/2019

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?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 10/31/2020
• Device Lot Number: T48943
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 02/12/2019
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 03/20/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention