MAUDE Adverse Event Report: ANGELINI THERMACARE LOWER BACK & HIP 8HR L/XL 2CT; HOT OR COLD DISPOSABLE PACK.

Model Number	ThermaCare HeatWraps - Lower Back & Hip
Medical Device Problem Code	Off-Label Use (1494)
Health Effect - Clinical Codes	Pain (1994); Blister (4537)
Date of Event	06/21/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The root cause can not be identified.There was limited device-specific information provided, not 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 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 consumer receiving blisters from the product.A 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 from a consumer regarding an (b)(6) male who used thermacare lower back and hip 8 hr l/xl 2ct.Medical history included diverticulitis and the patient was a non-smoker.The consumer declined to provide additional information regarding medical history and of any usage of concomitant products.Approximately 3 to 4 days ago, relative to (b)(6) 2021, the consumer topically applied a thermacare lower back and hip 8 hr heat wrap (lot number and expiration date not provided) to his lower back and hips.He left the product on longer than 8 hours.He did not realize it had limitations.He could not say how long he left it on exactly, but it was several hours longer than it should have been.Approximately 2 days ago, relative to (b)(6) 2021, the consumer noticed stinging where the patch was and he also had blisters.The blisters had popped.For treatment, the consumer had been applying foille burn medication and neosporin to the area.On (b)(6) 2021, the consumer visited his healthcare provider (hcp).The hcp told him he had a slight burn from the product, but it was not very bad and that the hcp had seen much worse.It was reported , that the hcp stated the blisters and the stinging were probably caused by the product and that he should continue to use the neosporin ointment.No follow up appointment was scheduled as the hcp did not think the burn was bad.No other treatments were provided.The consumer no longer had the product and could not provide additional device identifiers.

• Brand Name: THERMACARE LOWER BACK & HIP 8HR L/XL 2CT
• Common Device Name: HOT OR COLD DISPOSABLE PACK.
• Manufacturer (Section D): ANGELINI; 1231 wyandotte dr; albany GA 31705
• MDR Report Key: 12173332
• Report Number: 3007593958-2021-00023
• Device Sequence Number: 1492899
• Product Code: IMD
• UDI-Device Identifier: 00305733010037
• UDI-Public: 00305733010037
• Combination Product (Y/N): N
• Initial Reporter State: IN
• 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): 07/15/2021

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 - Lower Back & Hip
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/23/2021
• Initial Report FDA Received Date: 07/15/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Weight: 82