MAUDE Adverse Event Report: BRIDGES CONSUMER HEALTHCARE THERMACARE MENSTRAL CRAMP PORTABLE HEATING PADS HEATING; PACK, HOT OR COLD, DISPOSABLE

Patient Problems Partial thickness (Second Degree) Burn (2694); Blister (4537)

Event Date 11/09/2023

Event Type  Injury  

Event Description

Burns and blisters from using as directed thermacare menstrual heat pads on my 13 yr old daughter.No warning that this product could burn her so badly.

• Brand Name: THERMACARE MENSTRAL CRAMP PORTABLE HEATING PADS HEATING
• Type of Device: PACK, HOT OR COLD, DISPOSABLE
• Manufacturer (Section D): BRIDGES CONSUMER HEALTHCARE
• MDR Report Key: 18132212
• MDR Text Key: 328226184
• Report Number: MW5148106
• 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 Family Member or Friend
• Type of Report: Initial
• Report Date: 11/10/2023

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?: No
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 11/13/2023
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Sex: Female
• Patient Weight: 56 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White