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

Device Problem Insufficient Information (3190)

Patient Problems Burn(s) (1757); Erythema (1840); Skin Erosion (2075); Skin Tears (2516)

Event Date 06/07/2022

Event Type  Injury  

Manufacturer Narrative

The root cause cannot be identified.There is limited device specific information provided, no batch number was available for evaluation.Without a batch reference number a manufacturing and technical evaluation cannot be completed for the wrap involved in this case.No product quality related trend identified for the subclass adverse event safety request for investigation.Care should be taken when using the device, following all safety and use information as provided with the wrap to avoid the risk of blisters and other skin irritations.The manufacturing operations employ quality control procedures which include in process testing, thermal testing and visual inspection, to ensure packaged product quality.

Event Description

On (b)(6) 2022, a spontaneous report from the united states was received via telephone from a consumer regarding a 72-year-old male who used a thermacare lower back and hip 8hr l/xl heatwrap.Medical history included back pain, hypertension, and the reporter declined to provide further medical history.Concomitant products included an unspecified medication for hypertension, unspecified medications, and the reporter declined to provide further concomitant products.At approximately 6 am on (b)(6) 2022, the consumer used a thermacare lower back and hip 8hr l/xl topically over a t-shirt to the lower back for back pain.Approximately at noon on the same day, the consumer felt his back was really burning.It "burned his skin off".Subsequently, he took the product off.It was clarified that he observed a dime sized area of the skin on this low back which came off and stuck to his shirt.It looked raw and red.No treatment was performed, and medical attention was not sought.As of (b)(6) 2022, the area was no longer open and was healing well.No additional information was provided.

• Brand Name: THERMACARE LOWER BACK AND HIP 8HR L/XL
• 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: 14830155
• MDR Text Key: 295116714
• Report Number: 3007593958-2022-00038
• Device Sequence Number: 1
• Product Code: IMD
• 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: Other
• Type of Report: Initial
• Report Date: 06/24/2022

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
• Device Operator: Lay User/Patient
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 06/08/2022
• Initial Date FDA Received: 06/27/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: UNSPECIFIED MEDICATION FOR HYPERTENSION; UNSPECIFIED MEDICATION(S)
• Patient Outcome(s): Required Intervention
• Patient Age: 72 YR
• Patient Sex: Male