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

Model Number	ThermaCare HeatWraps - Lower Back & Hip
Medical Device Problem Code	Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Codes	Burn(s) (1757); Erythema (1840); Skin Discoloration (2074); Skin Erosion (2075)
Date of Event	07/13/2022
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 " the consumer noticed stinging where the patch was and he also had blisters".The cause of the consumer stating she received blisters 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 burn; a risk calculation cannot be determined as there is no reasonable suggestion of a device malfunction.
Event or Problem Description
On (b)(6) 2022, a spontaneous report from the united states was received regarding a 62-year-old male who used thermacare lower back & hip 8hr l/xl heat wrap.Medical history included high cholesterol, anxiety, hip pain, an artificial hip, diabetes, human immunodeficiency virus, and an allergy to calamine lotion.The consumer used unspecified medications (declined to provide).On (b)(6) 2022, the consumer topically applied a thermacare lower back & hip 8hr l/xl heat wrap directly to the skin of his lower back and went to bed at 10 am.At 5 pm the same day, after waking up and after 8 hours of use, he removed the wrap.He had an acid mark on his back.It was clarified that the heat wrap left a red, raw mark right where he put the wrap.It burned him "really bad".For treatment, he cleaned the area and anticipated following up with his medical doctor for treatment.The consumer noted he realized that he put the wrap directly on his skin even though the label indicates to use a clothing barrier if above the age of 55.It was the first time he used the heat wrap.

• Brand Name: THERMACARE LOWER BRACK & HIP L/XL 8HR
• 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: 15095128
• Report Number: 3007593958-2022-00050
• Device Sequence Number: 5323046
• Product Code: IMD
• UDI-Device Identifier: 00305733010037
• UDI-Public: 00305733010037
• Combination Product (Y/N): N
• Initial Reporter State: ME
• 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: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 07/25/2022

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: 12/31/2024
• Device Model Number: ThermaCare HeatWraps - Lower Back & Hip
• Device Lot Number: GA0366
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/15/2022
• Initial Report FDA Received Date: 07/25/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/05/2022
• 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: UNSPECIFIED MEDICATIONS
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 62 YR
• Patient Sex: Male