MAUDE Adverse Event Report: ANGELINI THERMACARE MENSTRUAL 8HR 3CT; HOT OR COLD DISPOSABLE PACK.

Model Number	ThermaCare HeatWraps - Menstrual
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Partial thickness (Second Degree) Burn (2694)
Date of Event	06/27/2022
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 had red areas like a burn on the left side of her pelvic region.A blister had formed in the area".The cause of the consumer stating she had red areas like a burn on the left side of her pelvic region and a blister had formed in the area 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.This is an adverse event for a red areas and a blister; risk calculation cannot be determined as there is no reasonable suggestion of a device malfunction.
Event or Problem Description
On 29-jun-2022, a spontaneous report from the united states was received via telephone regarding a 33-year-old female who used thermacare menstrual 8hr heat wrap.Medical history included prior use of a heat wrap without event.Concomitant products included mucinex (guaifenesin).On (b)(6) 2022, the consumer topically applied a thermacare heat wraps menstrual pain therapy on the middle of the stomach below the belly button for an unspecified indication.After taking the device off after 7 hours, she took the heat wrap off and noticed that she had red areas like a burn on the left side of her pelvic region.A blister had formed in the area.For treatment she covered the area with a band aid.She did not seek any medical attention for her symptoms.The consumer was watching the area closely.The consumer noted if she still had a blister by the end of the week of (b)(6) 2022, she would seek medical attention.No additional information was provided.

• Brand Name: THERMACARE MENSTRUAL 8HR 3CT
• 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: 15016113
• Report Number: 3007593958-2022-00045
• Device Sequence Number: 17856457
• Product Code: IMD
• UDI-Device Identifier: 00305733020029
• UDI-Public: 00305733020029
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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: Other
• Type of Report: Initial
• Report Date (Section B): 07/12/2022

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: 06/30/2024
• Device Model Number: ThermaCare HeatWraps - Menstrual
• Device Lot Number: GA0074
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/29/2022
• Initial Report FDA Received Date: 07/14/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/10/2021
• 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
• Concomitant Medical Products and Therapy/Usage Dates: MUCINEX (GUAIFENESIN)
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 33 YR
• Patient Sex: Female