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	Skin Discoloration (2074); Partial thickness (Second Degree) Burn (2694)
Date of Event	09/01/2022
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 "experienced a blister burn".The cause of the consumer stating she experienced a blister 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 blisters or other skin irritations.
Event or Problem Description
On 02-sep-2022 a spontaneous report from the united states was received via telephone regarding a female in her 30's who used a thermacare menstrual 8hr heat wrap.Medical history included asthma attacks and prior use of thermacare without incident for years.Concomitant products were not provided.On an unspecified date in (b)(6) 2022, the consumer topically applied a thermacare menstrual heat wrap.On an unspecified date in (b)(6) 2022, the consumer experienced a blister burn.One cell inside the wrap became hotter than the others and she developed a burn after applying it.The consumer was noted to have used the heat wrap correctly and without a heating pad.The consumer's mother was a nurse who treated her symptoms with antibiotic ointment and applied honey in between applications of the antibiotic ointment.On (b)(6) 2022, the consumer's blister popped and was purple in color.No additional information was provided.

• 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 ; 4237178579
• MDR Report Key: 15458866
• Report Number: 3007593958-2022-00059
• Device Sequence Number: 20543491
• Product Code: IMD
• UDI-Device Identifier: 00305733020029
• UDI-Public: 00305733020029
• Combination Product (Y/N): N
• Initial Reporter State: MD
• 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): 09/20/2022

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?: Yes
• Operator of Device: Lay User/Patient
• Device Model Number: ThermaCare HeatWraps - Menstrual
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/02/2022
• Initial Report FDA Received Date: 09/20/2022
• 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
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 30 YR
• Patient Sex: Female