MAUDE Adverse Event Report: BRIDGES CONSUMER HEALTHCARE THERMACARE HEAT WRAP; ON 13-DEC-2023 A SPONTANEOUS REPORT FROM THE UNITED STATES WAS RECEIVED VIA EMAI

Device Problem Insufficient Information (3190)

Patient Problem Burn(s) (1757)

Event Type  Injury  

Event Description

On 13-dec-2023 a spontaneous report from the united states was received via email regarding a consumer (age and sex unknown) who used a thermacare heat wrap.On an unspecified date, the consumer topically applied an unspecified thermacare heat wrap for heat therapy to the back.After using the product for a couple of hours, the patient reported experiencing a "chemical" burn which was impacted their home and work life.No further information was provided.

Manufacturer Narrative

Additional manufacturer narrative: the root cause and root cause sub class cannot be identified.There was limited device-specific information provided, not batch number or return sample was available for evaluation.Without a batch reference number or a return sample, a manufacturing and technical evaluation cannot be completed for the wrap involved in this case.There is not a product quality-related trend identified for the subclass adverse event safety request for investigation.The manufacturing operation employ quality control procedures, which include in- process testing, thermal testing, and visual inspection, to ensure the quality of the packaged product.This is an adverse event for a burn and a risk calculation cannot be determined as there is no known batch number to identify if there were a device malfunction.

• Brand Name: THERMACARE HEAT WRAP
• Type of Device: ON 13-DEC-2023 A SPONTANEOUS REPORT FROM THE UNITED STATES WAS RECEIVED VIA EMAI
• Manufacturer (Section D): BRIDGES CONSUMER HEALTHCARE; 811 broad street; suite 600; chattanooga TN 37402
• Manufacturer (Section G): ANGELINI; 1231 wyandotte dr; albany GA 31705
• Manufacturer Contact: rebecca ethridge ; 1231 wyandotte dr; albany, GA 31705 ; 2294463085
• MDR Report Key: 18399959
• MDR Text Key: 331412504
• Report Number: 3007593958-2023-00087
• Device Sequence Number: 1
• Product Code: IMD
• UDI-Device Identifier: 00305733010396
• UDI-Public: 305733010396
• 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: 12/26/2023

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
• Initial Date Manufacturer Received: 12/13/2023
• Initial Date FDA Received: 12/27/2023
• 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