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	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Pain (1994); Partial thickness (Second Degree) Burn (2694)
Date of Event	11/30/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The root cause cannot be identified.The site investigated this complaint by reviewing the device history records and manufacturing controls.The review of the device history records, batch thermal records, and production controls met the product release criteria.Consumer reports "burns and blisters after using the product for approximately 8 hours." the cause of the consumer stating she had "burns and blisters after using the product for approximately 8 hours" is inconclusive since review of records does not provide evidence to support defective product.The product effect may vary with each individual.Care should be taken when using the device, following all safety and use information as provided with the wrap to avoid the risks of blisters or other skin irritations.This is an adverse event for an burns and blisters after using the product for approximately 8 hours; risk calculation cannot be determined as there is no reasonable suggestion of a device malfunction.
Event or Problem Description
On (b)(6) 2021, a spontaneous report from the united states was received via email regarding a (b)(6) female who was using thermacare neck/shoulder/wrist 8hr.Medical history included seasonal allergies, arthritis, diabetes, acid reflux, and a kidney transplant in 2018.Concomitant products included prograff (tacrolimus), mycophenolate, vitamin d, vitamin b12, multivitamin, and omeprazole.On (b)(6) 2021, the consumer started treatment with thermacare neck/shoulder/wrist 8hr (lot number lot eh5503; expiration date 29-feb-2024) applied topically for an unspecified indication.After applying the product for 8 hours, she experienced having blisters.It was clarified as 2 blisters on her neck.One blister was slightly larger than a quarter and the other one was smaller.They were bubble-like in appearance.The consumer denied applying additional heat or coverings over the top of the heat wrap.She no longer was able to use the wrap longer than 8 hours.She was in severe pain.She was unsure if she could do her job due to the pain from the burns.One blister opened immediately, and the other blister opened up later that night.The area was very red, irritated, and painful.For treatment she covered the area with a bandage and over-the-counter antibiotic cream.She was told the open wounds appeared infected and they developed discharge.She no longer wore bandages because they further irritated the areas.She had been wanting to visit the urgent care, but it was closed by the time she got off of work.As of (b)(6)2021, she was experiencing an ongoing burning sensation.No additional information was provided.

• Brand Name: THERMACARE NECK/SHOULDER/WRIST 8HR 3CT
• Common Device Name: HOT OR COLD DISPOSABLE PACK.
• Manufacturer (Section D): ANGELINI; 1231 wyandotte dr; albany FL 31705
• Manufacturer (Section G): BRIDGES CONSUMER HEALTHCARE; 811 broad street, suite 600; chattanooga TN 37402
• Manufacturer Contact: steve weisman ; 811 broad street, suite 600; chattanooga, TN 37402 ; 9738891600
• MDR Report Key: 13112899
• Report Number: 3007593958-2021-00048
• Device Sequence Number: 3295733
• Product Code: IMD
• UDI-Device Identifier: 00305733015025
• UDI-Public: 00305733015025
• Combination Product (Y/N): N
• Initial Reporter State: AL
• 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): 12/28/2021

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 Expiration Date: 02/29/2024
• Device Model Number: ThermaCare HeatWraps - Neck, Wrist & Shoulder
• Device Lot Number: EH5503
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/02/2021
• Initial Report FDA Received Date: 12/29/2021
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/15/2021
• 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: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: MULTIVITAMIN.; MYCOPHENOLATE.; OMEPRAZOLE.; PROGRAFF (TACROLIMUS); VITAMIN B12.; VITAMIN D.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 48 YR
• Patient Sex: Female
• Patient Weight: 75 KG