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

Model Number	ThermaCare HeatWraps - Lower Back & Hip
Medical Device Problem Code	Off-Label Use (1494)
Health Effect - Clinical Codes	Erythema (1840); Burning Sensation (2146); Blister (4537)
Date of Event	03/21/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The root cause cannot be identified.The manufacturing 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 "she experienced a burning sensation and a blister".The cause of the consumer stating "she experienced a burning sensation and a blister" 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 a burning sensation and a blister; a risk calculation cannot be determined as there is no reasonable suggestion of a device malfunction.
Event or Problem Description
On 22-mar-2022, a spontaneous report from the united states was received from a consumer via telephone regarding a (b)(6) african american female who used a thermacare lower back and hip 8hr l/xl heat wrap.Medical history included high blood pressure and type ii diabetes.The consumer was allergic to seafood and was a non-smoker.Concomitant products included metformin and hydrochlorothiazide.At 6:00 on (b)(6) 2022, the consumer topically applied a thermacare lower back and hip 8hr l/xl heat wrap to her lower back for an unspecified indication.At 16:00 on (b)(6)2022, the consumer took the heat wrap off.She experienced a burning sensation and a blister.For treatment she washed the area with warm water with soap and applied neosporin.She worked at a healthcare facility and the nurses where she worked advised her to use over-the-counter (otc) burn cream.Subsequently, she had been applying neosporin and an otc burn cream.As of (b)(6 )2022, the area was much better, and she no longer had the blister or burning pain.The area where the device was placed was still pinkish and it was resolving.She did not seek medical attention.No additional information was provided.

• Brand Name: THERMACARE LOWER BACK & HIP 8HR L/XL
• 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: 14106266
• Report Number: 3007593958-2022-00021
• Device Sequence Number: 17312504
• Product Code: IMD
• UDI-Device Identifier: 00305733010037
• UDI-Public: 00305733010037
• 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): 04/11/2022

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: 08/01/2024
• Device Model Number: ThermaCare HeatWraps - Lower Back & Hip
• Device Lot Number: GA0105
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/22/2022
• Initial Report FDA Received Date: 04/13/2022
• Date Device Manufactured: 09/01/2021
• 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: Unknown
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: HYDROCHLOROTHIAZIDE; METFORMIN
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 48 YR
• Patient Sex: Female
• Patient Weight: 113 KG
• Patient Race: Black Or African American