MAUDE Adverse Event Report: ANGELINI THERMACARE NECK/SHOULDER/WRIST 8HR 3CT; HOT OR COLD DISPOSABLE PACK.

Model Number	ThermaCare HeatWraps - Neck, Wrist & Shoulder
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Erythema (1840); Scar Tissue (2060); Superficial (First Degree) Burn (2685); Swelling/ Edema (4577)
Date of Event	10/25/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
On 26-oct-2021, a spontaneous report from the united states via telephone was received regarding a female consumer (age not reported) who was using thermacare neck/shoulder/wrist 8hr.Medical history included prior use of thermacare heat wraps without issue.Concomitant products were not provided.On an unspecified date approximately on (b)(6) 2021 or the (b)(6) 2021, the consumer applied a using thermacare neck/shoulder/wrist 8hr heat wrap to her neck for an unspecified indication.On an unspecified date approximately on (b)(6) 2021 or the (b)(6) 2021, after 12 to 15 minutes of device application, the consumer went to the bathroom and looked in the mirror.Her neck was red and she was burned.The next morning, "they were puffy scars".Additional information was not provided as the reporter declined further participation in the adverse event process.
Additional Manufacturer Narrative
The root cause cannot be identified.There was limited device-specific information provided, no 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 "neck was red and she was burned[?].There were puffy scars".A risk calculation cannot be determined as there is no reasonable suggestion of a device malfunction.

• Brand Name: THERMACARE NECK/SHOULDER/WRIST 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; 1100 market street suite 600; chattanooga TN 37402
• Manufacturer Contact: steve weisman ; 1100 market street suite 600; chattanooga, TN 37402 ; 9738891619
• MDR Report Key: 12844960
• Report Number: 3007593958-2021-00044
• Device Sequence Number: 19921625
• Product Code: IMD
• UDI-Device Identifier: 00305733015025
• UDI-Public: 00305733015025
• 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): 11/03/2021

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 - Neck, Wrist & Shoulder
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/26/2021
• Initial Report FDA Received Date: 11/19/2021
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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 Sex: Female