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	Excessive Heating (4030)
Health Effect - Clinical Codes	Burning Sensation (2146); Skin Tears (2516)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The root cause cannot be identified.There was limited device-specific information provided, not batch number or return sample was available for evaluation.Without a batch reference number or a return sample, a manufacturing and technical evaluation cannot be completed for the wrap involved in this case.There is not a product quality-related trend identified for the subclass adverse event safety request for investigation.The manufacturing operation employ quality control procedures, which include in- process testing, thermal testing, and visual inspection, to ensure the quality of the packaged product.This is an adverse event for the product "the consumer experienced feeling that the product burns extremely bad".A risk calculation cannot be determined as there is no reasonable suggestion of a device malfunction.
Event or Problem Description
On 23-apr-2021, a spontaneous report was received from a consumer via a pharmaceutical company (reference number: 13927808) regarding a female consumer (age not reported) who used the thermacare menstrual 8hr 3ct heat wrap (lot number: 496668, expiration date: 13-may-2022).Medical history and concomitant products were not provided.On an unspecified date, on or before 13-feb-2021, the consumer topically applied the thermacare menstrual 8hr 3ct heat wrap for an unspecified indication to her stomach.On an unspecified date after applying the product, the consumer experienced feeling that the product burns extremely bad.When the product was pulled off it peeled her skin off.It was further clarified as, it took a layer of her skin off.No additional information was provided.Multiple follow up attempts were initiated but were unsuccessful.

• 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: 11862989
• Report Number: 3007593958-2021-00014
• Device Sequence Number: 3402434
• 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): 05/21/2021

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?: Yes
• Operator of Device: Lay User/Patient
• Device Expiration Date: 05/13/2022
• Device Model Number: ThermaCare HeatWraps - Muscle & Joint
• Device Lot Number: 496668
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/23/2021
• Initial Report FDA Received Date: 05/21/2021
• 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