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	Ulcer (2274)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The root cause is intentional device misuse by the consumer.The consumer noted that they used the thermacare menstrual heatwrap while they slept.The thermacare labeling and instructions for use provide guidance for the customer to prevent injury during use.The packaging instruction warns the consumer "do not wear while sleeping" and "check skin frequently during use".Care should be taken when using the device, following all safety and use information as provided with the wrap to avoid the risk of burn and other skin irritations.The manufacturing operations employ quality control procedures which include in process testing, thermal testing and visual inspection to ensure packaged product quality.There are pre identified risk factors that could cause a burn/blister listed in the hazard analysis (rpt-000097160).In addition to these hazards, there are multiple risks that are outside the control of the site.These include things like age, skin conditions, medical conditions, device use error and off-label use.The warning labels on our products are used to address these risks and relay the appropriate instructions for use to our customers to avoid burns, blisters and skin irritations.
Event or Problem Description
On (b)(6) 2026, this report was received from a consumer regarding a female consumer (age not provided) in association with a thermacare menstrual heat wrap.On an unspecified date, the consumer attached a thermacare menstrual heat wrap to her underwear and slept.After an unspecified amount of time of wearing the heat wrap, the consumer woke up and had an open sore on the lower left of her abdomen.She noted she slept on her back and there was not any extra pressure applied to the heat wrap.Follow-up attempts were unsuccessful in obtaining additional information.

• Brand Name: THERMACARE MENSTRUAL
• Common Device Name: HOT OR COLD DISPOSABLE PACK.
• Manufacturer (Section D): BRIDGES CONSUMER HEALTHCARE; 1208 king st; suite 605; chattanooga TN 37403
• Manufacturer (Section G): ANGELINI; 1231 wyandotte dr; albany GA 31705
• Manufacturer Contact: tonya blackwell ; 1231 wyandotte dr; albany, GA 31705 ; 2294463083
• MDR Report Key: 25398817
• Report Number: 3007593958-2026-00026
• Device Sequence Number: 10700331
• 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): Unknown
• Reporter Type: Manufacturer
• Report Source: Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 06/04/2026

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
• Operator of Device: Lay User/Patient
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/13/2026
• Initial Report FDA Received Date: 06/04/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Female