MAUDE Adverse Event Report: BRIDGES CONSUMER HEALTHCARE THERMACARE MENSTRUAL; HOT OR COLD DISPOSABLE PACK.

Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Full thickness (Third Degree) Burn (2696)
Date of Event	12/15/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The root cause and root cause sub class cannot be identified.There was limited device-specific information provided, not batch number or return sample was available for evaluation.Without a batch reference number or a return sample, a manufacturing and technical evaluation cannot be completed for the wrap involved in this case.There is not a product quality-related trend identified for the subclass adverse event safety request for investigation.The manufacturing operation employ quality control procedures, which include in- process testing, thermal testing, and visual inspection, to ensure the quality of the packaged product.This is an adverse event for a burn and a risk calculation cannot be determined as there is no known batch number to identify if there were a device malfunction.
Event or Problem Description
On 17-dec-2023, a spontaneous report from the united states via email was received regarding a 22-year-old female consumer who used a thermacare menstrual heat pad.On 19-dec-2023, additional information was received.On (b)(6) 2023, the consumer applied a thermacare menstrual heat pad topically to her lower abdomen.Approximately 2 minutes after applying the product, she heard a loud popping sound.She noted that one of the heat cells exploded and she obtained a 1.5-to-2-inch burn on her abdomen.She removed the heat wrap.She removed the heat wrap immediately but it was difficult to remove.She felt it was stuck to her.The color of the heat wrap had changed.The area was painful when her clothing rubbed on it and she went to a doctor the same day.She was diagnosed with a third-degree burn.She was prescribed unspecified pain medications, antibiotics, and an ointment to put on her burn.She noted the antibiotic was prescribed to prevent an infection and not to use the product again.She anticipated having a follow up appointment on (b)(6) 2023.

• Brand Name: THERMACARE MENSTRUAL
• Common Device Name: HOT OR COLD DISPOSABLE PACK.
• Manufacturer (Section D): BRIDGES CONSUMER HEALTHCARE; 811 broad street; suite 600; chattanooga TN 37402
• Manufacturer (Section G): ANGELINI; 1231 wyandotte dr; albany GA 31705
• Manufacturer Contact: rebecca ethride ; 1231 wyandotte dr; albany, GA 31705 ; 2294463085
• MDR Report Key: 18489600
• Report Number: 3007593958-2024-00090
• Device Sequence Number: 7056677
• Product Code: IMD
• UDI-Device Identifier: 00305733010396
• UDI-Public: 305733010396
• Combination Product (Y/N): N
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 01/04/2024

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?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/17/2023
• Initial Report FDA Received Date: 01/10/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 22 YR
• Patient Sex: Female
• Patient Weight: 54 KG