MAUDE Adverse Event Report: ANGELINI THERMACARE MENSTRUAL 8HR HEAT WRAP; HOT OR COLD DISPOSABLE PACK.

Lot Number GA0734N

Device Problem Insufficient Information (3190)

Patient Problems Burn(s) (1757); Peeling (1999); Rash (2033)

Event Date 04/12/2023

Event Type  Injury  

Manufacturer Narrative

The root cause cannot be identified.The site investigated this complaint by reviewing the device history records and manufacturing controls.The review of the device history records, batch thermal records, and production controls met the product release criteria.Consumer reports " she experienced a burn.It was like a "rash burn".The cause of the consumer stating she received a burn is inconclusive since review of records does not provide evidence to support defective product.The product effect may vary with each individual.Care should be taken when using the device, following all safety and use information as provided with the wrap to avoid the risks of burns or other skin irritations.This is an adverse event for a burn; risk calculation cannot be determined as there is no reasonable suggestion of a device malfunction.

Event Description

On 12-apr-2023, a spontaneous report from the united states was received via email from a consumer regarding a female (age was not provided) who used a thermacare menstrual 8hr heat wrap.On an unspecified date, the consumer used a thermacare menstrual heat wrap.On an unspecified date after using the thermacare menstrual heat wrap, she experienced a burn.It was like a "rash burn".She sent a picture to her doctor, and she was prescribed a cream (unspecified).On (b)(6) 2023, she noticed her skin was peeling.No additional information was provided.

• Brand Name: THERMACARE MENSTRUAL 8HR HEAT WRAP
• Type of Device: HOT OR COLD DISPOSABLE PACK.
• Manufacturer (Section D): ANGELINI; 1231 wyandotte dr.; albany GA 31705
• Manufacturer (Section G): BRIDGES CONSUMER HEALTHCARE; 811 broad street, suite 600; chattanooga TN 37402
• Manufacturer Contact: scott hughes ; 811 broad street, suite 600; chattanooga, TN 37402 ; 4234142221
• MDR Report Key: 16870596
• MDR Text Key: 314588743
• Report Number: 3007593958-2023-00025
• Device Sequence Number: 1
• Product Code: IMD
• UDI-Device Identifier: 00305733010396
• UDI-Public: 305733010396
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 05/04/2023

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
• Device Operator: Lay User/Patient
• Device Lot Number: GA0734N
• Initial Date Manufacturer Received: 04/12/2023
• Initial Date FDA Received: 05/04/2023
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Sex: Female