MAUDE Adverse Event Report: ANGELINI PHARMA INC. THERMACARE WRAP; PACK, HOT OR COLD, DISPOSABLE

Device Problem Use of Device Problem (1670)

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

Event Date 03/30/2023

Event Type  Injury  

Event Description

I have a burn about the size of a half dollar (at least second degree, top layer of skin was completely gone) on my skin from one cell of a thermacare heat pack.The cell directly adjacent has a small minor burn.

• Brand Name: THERMACARE WRAP
• Type of Device: PACK, HOT OR COLD, DISPOSABLE
• Manufacturer (Section D): ANGELINI PHARMA INC.
• MDR Report Key: 16683987
• MDR Text Key: 312937705
• Report Number: MW5116353
• 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: 04/01/2023

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?: Yes
• Device Operator: Lay User/Patient
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 04/04/2023
• Patient Sequence Number: 1
• Treatment: TYLENOL.
• Patient Outcome(s): Other
• Patient Age: 39 YR
• Patient Sex: Female
• Patient Weight: 54 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White