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 Excessive Heating (4030)

Patient Problems Burn(s) (1757); Erythema (1840); Pain (1994)

Event Date 03/30/2022

Event Type  malfunction  

Manufacturer Narrative

The root cause cannot be identified.There is limited device specific information provided, no batch number or return sample was available for evaluation.Without a batch reference number or return sample, a manufacturing and technical evaluation cannot be completed for the wrap involved in this case.No product quality related trend identified for the subclass adverse event safety request for investigation.Care should be taken when using the device, following all safety and use information as provided with the wrap to avoid the risk of blisters and other skin irritations.The manufacturing operations employ quality control procedures which include in process testing, thermal testing and visual inspection, to ensure packaged product quality.

Event Description

On 31-mar-2022, a spontaneous report from the united states was received from a consumer via telephone regarding a female (age not provided) who used a thermacare neck/shoulder/wrist 8hr heat wrap.Medical history included prior use of thermacare heat wraps without issue and a fractured neck resulting in pain.Concomitant products were not provided.On (b)(6) 2022, the consumer topically applied a thermacare neck/shoulder/wrist 8hr heat wrap across her shoulder area around her neck as it looked on the packaging for pain.Approximately 6.5 hours after topically applying the heat wrap, the consumer noted that the heat wrap become really hot at one point.She thought it was just a reaction that her body was giving her, and she did not mind until she felt a very painful sting.Subsequently, she removed the product.Her friend, who was a health care professional, looked at the area because the consumer could not see the area where it was applied.Her friend confirmed that she received a burn from the patch and the areas surrounding it were very red.The consumer declined to provide further information.

• 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; 811 broad street, suite 600; chattanooga TN 37402
• Manufacturer Contact: scott hughes ; 811 broad street, suite 600; chattanooga, TN 37402 ; 4237178579
• MDR Report Key: 14120444
• MDR Text Key: 298804377
• Report Number: 3007593958-2022-00023
• 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: 04/15/2022

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?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: ThermaCare HeatWraps - Neck, Wrist & Shoulder
• Device Lot Number: ZA0172
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 03/31/2022
• Initial Date FDA Received: 04/15/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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