MAUDE Adverse Event Report: ANGELINI THERMACARE JOINT THERAPY 8HR 4CT; HOT OR COLD DISPOSABLE PACK

Model Number	ThermaCare HeatWraps - Flexible
Medical Device Problem Code	Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Codes	Pain (1994); Full thickness (Third Degree) Burn (2696)
Date of Event	04/01/2021
Type of Reportable Event	Serious Injury
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 "product used, led to burn, led to surgery.A risk calculation cannot be determined as there is no reasonable suggestion of a device malfunction.
Event or Problem Description
On 05-aug-2021, a spontaneous report from the united states was received from a consumer regarding an (b)(6) female consumer who used thermacare joint therapy 8 hr 4 ct (lot number and expiration date were not provided).Medical history included anxiety, acid reflux, diuretic therapy, hypertension, muscle relaxation therapy, back pain, cholesterol (not further specified), restless legs, bladder frequency, thermacare use for 20 years (without incident), and prophylactic therapy for utis (urinary tract infection).Concomitant products included nadolol, amlodipine, and benazepril for hypertension; baclofen for muscle relaxation; meloxicam and oxycodone for back pain; pravastatin for cholesterol; ropinirole for restless legs; tolterodine for bladder frequency; alprazolam and fluoxetine for anxiety; and vitamin c, vitamin d, a multivitamin, and calcium for nutritional supplementation.On (b)(6) 2021, the consumer topically applied on thermacare joint therapy 8 hr directly to her skin on her left knee for knee pain.She left the product on for approximately 8 hours.When she took the product of, the area was reddened.Within one to two weeks, she consumer showed the application area to her son, and it looked like a burn.On an unspecified date in the beginning of (b)(6) 2021, the consumer went to dermatologist who prescribed her an unspecified cream.She used the cream, but the area was not getting better.On an unspecified date in the end of (b)(6) 2021, she went to a burn clinic.The doctors diagnosed her with a third-degree burn.She was prescribed more cream (unspecified) and the area was bandaged.The burn was not improving, subsequently she developed an open wound.On (b)(6) 2021, she had surgery.The surgeon cleaned out the area to remove all the burned tissue.The area was stapled, and she had a cadaver skin covering placed.On (b)(6) 2021, the surgical site bandaged was unwrapped and rewrapped.On (b)(6) 2021, the consumer had a second surgery.The cadaver skin was removed, and she had a skin graft.Skin was taken from her thigh and then grafted on to her knee at the application site.On (b)(6) 2021, the consumer returned to the clinic and her bandaged was unwrapped so she could take a shower.As of (b)(6) 2021, she continues to use the cream and she and a follow-up visit with her surgeon was scheduled for (b)(6) 2021.No further information was provided.

• Brand Name: THERMACARE JOINT THERAPY 8HR 4CT
• Common Device Name: HOT OR COLD DISPOSABLE PACK
• Manufacturer (Section D): ANGELINI; 1231 wyandotte dr; albany GA 31705
• MDR Report Key: 12365380
• Report Number: 3007593958-2021-00031
• Device Sequence Number: 19767109
• Product Code: IMD
• UDI-Device Identifier: 00305733017241
• UDI-Public: 00305733017241
• 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): 08/25/2021

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 - Flexible
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/05/2021
• Initial Report FDA Received Date: 08/25/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: ALPRAZOLAM; AMLODIPINE; BACLOFEN; BENAZEPRIL; CALCIUM; FLUOXETINE; FUROSEMIDE; MELOXICAM; MULTIVITAMIN; NADALOL; NITROFURANTOIN; OXYCODONE; PANTOPRAZOLE; PRAVASTATIN; ROPINIROLE; TOLTERODINE; VITAMIN C; VITAMIN D
• Outcome Attributed to Adverse Event: Disability
• Patient Age: 87 YR
• Patient Weight: 64