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

Model Number	ThermaCare HeatWraps - Menstrual
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Itching Sensation (1943); Peeling (1999); Partial thickness (Second Degree) Burn (2694)
Date of Event	10/01/2022
Type of Reportable Event	Serious Injury
Additional 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 "noted blisters on her skin where the wrap was touching." the cause of the consumer stating she "noted blisters on her skin where the wrap was touching" 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 blisters or other skin irritations.
Event or Problem Description
On (b)(6) 2022, a spontaneous report from the united states was received via telephone regarding a 26-year-old female who used a thermacare menstrual 8hr heat wrap.The consumer was health and did not smoke.The consumer was allergic to sulfonamides.Concomitant products included a multivitamin.On (b)(6) 2022, the consumer used a thermacare menstrual 8hr heat wrap applied against her underwear and then attached it to wear around her abdomen.On (b)(6) 2022, after four to five hours of wearing the heat wrap and when she came back from work, she experienced itching on her skin underneath the patch.While she itched, she realized that her skin was coming up.She removed the wrap and examined her skin.She noted blisters on her skin where the wrap was touching.The skin looked burned to her.She noted she had second degree burns on her pubic area.She had been keeping the area clean but had not sought medical care or performed any other therapies.She noted she did not have any broken skin prior to wearing the heat wrap and did not use any creams or ointments prior to suing the heat wrap.When she felt itching, she went to scratch the skin and it started peeling off.As of (b)(6) 2022, the blisters had popped, and her symptoms persisted.

• Brand Name: THERMACARE MENSTRUAL 8HR
• Common Device Name: 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: 15601057
• Report Number: 3007593958-2022-00067
• Device Sequence Number: 2263729
• Product Code: IMD
• UDI-Device Identifier: 00305733020029
• UDI-Public: 00305733020029
• 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): 10/13/2022

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
• Device Expiration Date: 04/30/2025
• Device Model Number: ThermaCare HeatWraps - Menstrual
• Device Lot Number: GA0426 N
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/03/2022
• Initial Report FDA Received Date: 10/13/2022
• Date Device Manufactured: 05/02/2022
• 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: Unknown
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: MULTIVITAMIN.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 26 YR
• Patient Sex: Female