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

Model Number ThermaCare HeatWraps - Neck, Wrist & Shoulder

Device Problem Insufficient Information (3190)

Patient Problems Erythema (1840); Scar Tissue (2060); Superficial (First Degree) Burn (2685); Swelling/ Edema (4577)

Event Date 10/25/2021

Event Type  Injury  

Event 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.

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
• Type of Device: 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
• MDR Text Key: 285533910
• Report Number: 3007593958-2021-00044
• Device Sequence Number: 1
• Product Code: IMD
• UDI-Device Identifier: 00305733015025
• UDI-Public: 00305733015025
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 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
• Device Operator: Lay User/Patient
• Device Model Number: ThermaCare HeatWraps - Neck, Wrist & Shoulder
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 10/26/2021
• Initial Date FDA Received: 11/19/2021
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Sex: Female