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

Model Number ThermaCare HeatWraps - Lower Back & Hip

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problems Burn(s) (1757); Erythema (1840); Skin Discoloration (2074); Skin Erosion (2075)

Event Date 07/13/2022

Event Type  Injury  

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 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
• Type of Device: 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
• MDR Text Key: 296500760
• Report Number: 3007593958-2022-00050
• Device Sequence Number: 1
• Product Code: IMD
• UDI-Device Identifier: 00305733010037
• UDI-Public: 00305733010037
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 07/25/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/25/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: ThermaCare HeatWraps - Lower Back & Hip
• Device Lot Number: GA0366
• Date Manufacturer Received: 07/15/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/05/2022
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Treatment: UNSPECIFIED MEDICATIONS
• Patient Outcome(s): Required Intervention
• Patient Age: 62 YR
• Patient Sex: Male