MAUDE Adverse Event Report: ANGELINI PHARMA INC. THERMACARE MENSTRUAL PAIN THERAPY HEATWRAP; PACK, HOT OR COLD, DISPOSABLE

Lot Number GA0426 N

Device Problem Patient-Device Incompatibility (2682)

Patient Problems Peeling (1999); Skin Discoloration (2074); Partial thickness (Second Degree) Burn (2694); Blister (4537); Swelling/ Edema (4577)

Event Date 10/01/2022

Event Type  Injury  

Event Description

Wore thermacare menstrual heat wraps according to directions and experienced second degree burns.Burn included blistering, skin peeling, swelling, redness, and yellowing of the skin.Wrap was worn against skin according to package directions for approximately 5 hours.Product never felt overly hot.No preexisting conditions that would have caused skin to burn easily.(b)(6) healthcare.

• Brand Name: THERMACARE MENSTRUAL PAIN THERAPY HEATWRAP
• Type of Device: PACK, HOT OR COLD, DISPOSABLE
• Manufacturer (Section D): ANGELINI PHARMA INC.
• MDR Report Key: 15543746
• MDR Text Key: 301336371
• Report Number: MW5112440
• 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: 10/03/2022

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 Lot Number: GA0426 N
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 10/04/2022
• Patient Sequence Number: 1
• Patient Outcome(s): Disability
• Patient Age: 26 YR
• Patient Sex: Female
• Patient Weight: 108 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White