MAUDE Adverse Event Report: PFIZER INC. / BRIDGES CONSUMER HEALTHCARE THERMACARE BACK PAIN THERAPY HEATWRAPS, UP TO 16HR PAIN RELIEF; PACK, HOT OR COLD, DISPOSABLE

Device Problem Patient Device Interaction Problem (4001)

Patient Problems Pain (1994); Scar Tissue (2060); Superficial (First Degree) Burn (2685)

Event Date 12/01/2021

Event Type  Injury  

Event Description

Burned by back patches.Purchased thermacare patches at (b)(6) and when applied to my back area it burned my skin.Had pain and scaring.Back pain.

• Brand Name: THERMACARE BACK PAIN THERAPY HEATWRAPS, UP TO 16HR PAIN RELIEF
• Type of Device: PACK, HOT OR COLD, DISPOSABLE
• Manufacturer (Section D): PFIZER INC. / BRIDGES CONSUMER HEALTHCARE
• MDR Report Key: 12960607
• MDR Text Key: 281990954
• Report Number: MW5105901
• Device Sequence Number: 1
• Product Code: IMD
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 12/04/2021

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
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 12/07/2021
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 73 YR
• Patient Sex: Female
• Patient Weight: 101 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White