MAUDE Adverse Event Report: BRIDGES CONSUMER HEALTHCARE THERMACARE HEATWRAPS - ADVANCED BACK PAIN THERAPY; PACK, HOT OR COLD, DISPOSABLE

Lot Number EC7071

Device Problems Use of Device Problem (1670); Temperature Problem (3022)

Patient Problem Partial thickness (Second Degree) Burn (2694)

Event Date 11/05/2021

Event Type  Injury  

Event Description

Experienced 2nd degree burns after use of a thermacare heatwrap on lower back.

• Brand Name: THERMACARE HEATWRAPS - ADVANCED BACK PAIN THERAPY
• Type of Device: PACK, HOT OR COLD, DISPOSABLE
• Manufacturer (Section D): BRIDGES CONSUMER HEALTHCARE
• MDR Report Key: 12934006
• MDR Text Key: 281867532
• Report Number: MW5105802
• 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: Unknown
• Type of Report: Initial
• Report Date: 12/01/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/03/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Expiration Date: 07/31/2023
• Device Lot Number: EC7071
• Patient Sequence Number: 1
• Treatment: ASA TAMSULOSIN ; JARDIANCE; LISINOPRIL ; LYRICA
• Patient Age: 59 YR
• Patient Sex: Male
• Patient Weight: 108 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White