MAUDE Adverse Event Report: PF CONSUMER HEALTHCARE 1 LLC MENSTRUAL PAIN THERAPY 8HR; PACK HOT OR COLD DISPOSABLE

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Unspecified Infection (1930); Swelling (2091)

Event Date 03/29/2019

Event Type  Injury  

Event Description

I used a thermacare menstrual heat wrap and got blisters that popped and became infected.

• Brand Name: MENSTRUAL PAIN THERAPY 8HR
• Type of Device: PACK HOT OR COLD DISPOSABLE
• Manufacturer (Section D): PF CONSUMER HEALTHCARE 1 LLC
• MDR Report Key: 8504155
• MDR Text Key: 141782528
• Report Number: MW5085794
• Device Sequence Number: 0
• Product Code: IMD
• Combination Product (y/n): Y
• 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: 04/09/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Device Operator: No Information
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 04/10/2019
• Patient Sequence Number: 1
• Patient Age: 29 YR
• Patient Weight: 113