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

Device Problem Overheating of Device (1437)

Patient Problems Abrasion (1689); Burn(s) (1757); Discomfort (2330)

Event Date 04/19/2022

Event Type  Injury  

Manufacturer Narrative

The root cause cannot be identified.There is limited device specific information provided, no batch number or return sample was available for evaluation.Without a batch reference number or return sample, 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 21-apr-2022, a spontaneous report from the united states was received regarding a female consumer (age not provided) who used a thermacare lower back and hip 8hr l/xl heat wrap.Medical history and usage of concomitant products were not provided.On 19-apr-2022, the consumer topically applied a thermacare lower back and hip 8hr l/xl heat wrap to her lower back.Two hours after applying the heat wrap, she experienced that it tingled.The heat wrap was difficult to remove, and it became stuck to her.It left a flesh burn.It was also noted that she developed a burn which was further described as an abrasion burn.The consumer was not able to provide any further information about the device and declined to further participate in the adverse event process.No additional information is expected.

• Brand Name: THERMACARE LOWER BACK & HIP 8HR L/XL 2CT
• 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: 14412310
• MDR Text Key: 291805356
• Report Number: 3007593958-2022-00031
• 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: 05/13/2022

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: 04/21/2022
• Initial Date FDA Received: 05/16/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Sex: Female