MAUDE Adverse Event Report: ANGELINI THERMACARE LOWER BACK AND HIP; HOT OR COLD DISPOSABLE PACK.

Device Problem Insufficient Information (3190)

Patient Problem Scar Tissue (2060)

Event Type  malfunction  

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 was 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 17-jan-2022, a spontaneous report from the united states was received via phone, regarding a female consumer (age not provided) who purchased an unspecified thermacare lower back and hip heat wrap.Medical history and concomitant products were not provided.On an unspecified date, after purchasing a thermacare lower back and hip heat wrap, the cells crumbled to dust.She mentioned she experienced scarring and spoke to a couple of different doctors.She noted she would be going to the emergency room at some point.The consumer did not provide further detail regarding her experience.Follow up was unsuccessful in obtaining additional information.

• Brand Name: THERMACARE LOWER BACK AND HIP
• 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: 15964655
• MDR Text Key: 307820205
• Report Number: 3007593958-2022-00083
• 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: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 12/09/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Initial Date Manufacturer Received: 01/17/2022
• Initial Date FDA Received: 12/12/2022
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Sex: Female