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

Model Number	ThermaCare HeatWraps - Muscle & Joint
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Peeling (1999); Blister (4537)
Type of Reportable Event	Serious Injury
Event or Problem Description
On 14-sep-2021, a spontaneous report from the united states was received via telephone from a consumer regarding a female consumer who was using a thermacare menstrual 8hr heat wrap.Medical history included menstrual pain.Additional medical history and concomitant products were not provided.On an unspecified date, the consumer topically applied a thermacare menstrual 8hr heat wrap for menstrual pain.After the consumer wore a thermacare menstrual 8hr heat wrap for 8 hours while working, the consumer noted that the she had a blister, "like the first layer of skin was gone." follow up attempts have been attempted and unsuccesful in obtaining additional information.
Additional Manufacturer Narrative
The root cause cannot be identified.There was limited device-specific information provided, no batch numbers or return samples were available for evaluation.Without batch reference numbers, a manufacturing and technical assessment cannot be completed for the wraps involved in this case.No product quality-related trend was identified for the subclass adverse event safety request for investigation.The manufacturing operations employ quality control procedures, including in process testing, thermal testing, and visual inspection, to ensure the quality of the packaged 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 blister".A risk calculation cannot be determined as there is no reasonable suggestion of a device malfunction.

• Brand Name: THERMACARE MUSCLE/JOINT 8HR 3CT
• Common Device Name: HOT OR COLD DISPOSABLE PACK.
• Manufacturer (Section D): ANGELINI; 1231 wyandotte dr; albany GA 31705
• MDR Report Key: 12570335
• Report Number: 3007593958-2021-00038
• Device Sequence Number: 19843128
• Product Code: IMD
• UDI-Device Identifier: 00305733013038
• UDI-Public: 00305733013038
• 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: Other
• Type of Report: Initial
• Report Date (Section B): 10/04/2021

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 Model Number: ThermaCare HeatWraps - Muscle & Joint
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/14/2021
• Initial Report FDA Received Date: 10/04/2021
• 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