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 Codes	Use of Device Problem (1670); Temperature Problem (3022)
Health Effect - Clinical Codes	Pain (1994); Sleep Dysfunction (2517); Partial thickness (Second Degree) Burn (2694)
Date of Event	01/17/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
On (b)(6) 2022, a spontaneous report from the united states was received from a consumer regarding a (b)(6) male who was using a thermacare neck, shoulder, wrist 8hr heat wrap.Medical history included diabetes, hypertension, and pain.Concomitant products included metformin and an unspecified medication for hypertension.On (b)(6) 2022, the consumer topically applied a thermacare neck, shoulder, wrist 8hr (lot number: 0w7747; expiration date sep-2022) heat wrap to his left lower back for pain.After 2 hours of applying the product, the consumer took it off because he did not feel heat.He noted it did not heat up and it did not alleviate his pain.He did "some moving around" which triggered the pain.He then turned to the method of heating up rice in a sock via a microwave to bring comfort to the pain.He felt pain at the application site of the product and looked into the mirror.He then saw blisters at the application site.On an unspecified date, the consumer called his doctor and was advised to take ibuprofen.He was losing sleep because of the pain.He did not have a way to get to the doctor.It was the first and the last time he used the product.The consumer noted that it had been over a week and his blisters still hurt from the heat wrap.No additional information was provided.
Additional 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.

• 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; 811 broad street, suite 600; chattanooga TN 37402
• Manufacturer Contact: scott hughes ; 811 broad street, suite 600; chattanooga, TN 37402 ; 4237178579
• MDR Report Key: 13498684
• Report Number: 3007593958-2022-00002
• Device Sequence Number: 14481514
• Product Code: IMD
• UDI-Device Identifier: 00305733015025
• UDI-Public: 00305733015025
• Combination Product (Y/N): N
• Initial Reporter State: NV
• 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): 02/03/2022

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?: No
• Operator of Device: Lay User/Patient
• Device Expiration Date: 09/01/2022
• Device Model Number: ThermaCare HeatWraps - Neck, Wrist & Shoulder
• Device Lot Number: 0W7747
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/17/2022
• Initial Report FDA Received Date: 02/09/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: METFORMIN; UNSPECIFIED ANTI-HYPERTENSIVE MEDICATION
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 71 YR
• Patient Sex: Male
• Patient Weight: 77 KG