MAUDE Adverse Event Report: PFIZER THERMACARE MENSTRUAL; HEAT WRAPS

Lot Number L72538

Device Problem Temperature Problem (3022)

Patient Problems Pain (1994); Partial thickness (Second Degree) Burn (2694)

Event Date 08/12/2015

Event Type  Injury  

Event Description

Used a thermacare menstrual heat wrap for three hours.I felt pain in my abdomen so i moved the heat pad down and noticed i had burn blisters all over my lower abdomen.Some of them had already ruptured.

• Brand Name: THERMACARE MENSTRUAL
• Type of Device: HEAT WRAPS
• Manufacturer (Section D): PFIZER
• MDR Report Key: 5018960
• MDR Text Key: 23662101
• Report Number: MW5055608
• Device Sequence Number: 1
• Product Code: IMD
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Report Date: 08/13/2015

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: No Information
• Device Lot Number: L72538
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/13/2015
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 32 YR
• Patient Weight: 139