MAUDE Adverse Event Report: PFIZER CONSUMER HEALTH CARE THERMACARE HEATWRAP; DISPOSABLE PACK, HOT

Device Problems Adverse Event Without Identified Device or Use Problem (2993); Insufficient Information (3190)

Patient Problems Unspecified Infection (1930); Scarring (2061); Burn, Thermal (2530)

Event Date 06/11/2013

Event Type  Injury  

Event Description

Burns on her back [thermal burn]."treat me from infection [infection]." case description: this is a spontaneous report from a contactable consumer or other non hcp.A (b)(6) female pt started to receive thermacare heatwrap (thermacare heatwrap) from an unspecified date for back pain.The pt's medical history was not reported.There were no concomitant medications.On (b)(6) 2013, the pt was hospitalized for burns on her back from (b)(6) 2013.The consumer mentioned that she had recovered from her burns but scars were left.On an unspecified date in 2013, the consumer stated "they put a different cream on my back to treat me from infection".Action taken with the suspect product was unk.At the time of the report, the clinical outcome was recovered with sequelae.The skin tone of the consumer was reported as light.She did not use any creams, rubs or gels under the wrap and there were no defects on the wrap like cuts, tears, leaks or holes.The pt did not change or modify the wrap in anyway.She did not put the wrap in the microwave and did not exercise while using the wrap.Additional info has been requested and will be provided as it becomes available.

Manufacturer Narrative

Company comment: based on the available info, the company cannot exclude a possible contribution of the suspect device product to the events of burns that left scars on her back, and infection.This case is assessed as initial 30-day reportable case.

Manufacturer Narrative

Summary of investigation: this investigation was conducted for an unknown lot number lower back/hip (lbh) 8-hour product.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 adverse event safety request for investigation.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.Lot trend assmt.& rationale: a lot trend was not performed as the lot number is unknown.The sample had not been received by the site.

Event Description

Event verbatim [preferred term] burns on her back [thermal burn], treat me from infection [infection].Narrative: this is a spontaneous report from a contactable consumer.This consumer reported similar events different onset timeframe.This is the first of two reports.A 71-year-old female patient started to receive thermacare heatwrap (thermacare heatwrap) from an unspecified date for back pain.The patient's medical history was not reported.There were no concomitant medications.On (b)(6) 2013, the patient was hospitalized for burns on her back from (b)(6) 2013.The consumer mentioned that she had recovered from her burns but scars were left.On an unspecified date in 2013, the consumer stated "they put a different cream on my back to treat me from infection".Action taken with the suspect product was unknown.At the time of the report, the outcome of burns on her back was recovered with sequelae.The outcome of treat me from infection was unknown.The skin tone of the consumer was reported as light.She did not use any creams, rubs or gels under the wrap and there were no defects on the wrap like cuts, tears, leaks or holes.The patient did not change or modify the wrap in anyway.She did not put the wrap in the microwave and did not exercise while using the wrap.According to product quality complaint group: summary of investigation: this investigation was conducted for an unknown lot number lower back/hip (lbh) 8-hour product.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 adverse event safety request for investigation.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.Lot trend assmt.& rationale: a lot trend was not performed as the lot number is unknown.The sample had not been received by the site.Follow-up (24nov2014): new information received from a contactable physician includes: the physician denied being provided information regarding an adverse event with use of the product and could not confirm occurrence of the events reported by the patient.Follow-up (09mar2015): follow-up attempts completed.No further information expected.Follow-up (10jun2020): new information received from a product complaint group group included: investigation results.

• Brand Name: THERMACARE HEATWRAP
• Type of Device: DISPOSABLE PACK, HOT
• Manufacturer (Section D): PFIZER CONSUMER HEALTH CARE; 1231 wyandotte drive; albany, ga GA
• MDR Report Key: 4257354
• MDR Text Key: 5109780
• Report Number: 1066015-2014-00007
• 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,consumer,health profession
• Type of Report: Initial,Followup
• Report Date: 11/03/2014

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
• Initial Date Manufacturer Received: 11/03/2014
• Initial Date FDA Received: 11/13/2014
• Supplement Dates Manufacturer Received: 06/10/2020
• Supplement Dates FDA Received: 06/17/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 71 YR
• Patient Weight: 62