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); Caustic/Chemical Burns (2549)

Event Date 08/04/2019

Event Type  Injury  

Event Description

Chemical burns on her back/multiple burns to her lower back region [chemical burn], permanent scarring [scar].Case narrative: this is a spontaneous report from a contactable consumer.This female consumer of an unspecified age started to use thermacare heatwrap (thermacare lower back & hip l/xl) (device lot number and expiration date unknown) from an unspecified date for an unspecified indication.Relevant medical history and the relevant concomitant medications were unknown at the time of this report.The consumer stated that she used one thermacare heatwrap on her lower back and unfortunately received chemical burns on her back.Action taken with the thermacare therapy in response to the event and the outcome of the event were unknown at the time of this report.Per the product quality group, the severity of harm was selected as s3.Additional information has been requested and will be provided as it becomes available.Follow-up (09oct2019): new information received from product quality complaints includes severity of harm.Follow-up (22nov2019): follow-up attempts are completed.No further information is expected.Follow-up (13jan2020): new information received from a contactable attorney includes: the patient experienced burns on or about (b)(6) 2019 while using thermacare lower back and hip heat wrap product which she purchased at (pharmacy name).The patient was treated for multiple burns to her lower back region that have left permanent scarring.The outcome of the events was unknown.Per our information and investigation, the fda issued a recall of the above product on or about 26apr2019 due to similar excess heat-related issues.Case upgraded to a serious reportable mdr.

• 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
• Manufacturer Contact: stella pietrafesa ; 235 e42nd street; new york, NY 10017
• MDR Report Key: 9637283
• MDR Text Key: 189167947
• Report Number: 1066015-2020-00021
• Device Sequence Number: 1
• Product Code: IMD
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K953442
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 10/04/2019

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
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 01/28/2020
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention