MAUDE Adverse Event Report: BRIDGES CONSUMER HEALTHCARE THERMACARE HEAT WRAP; HOT OR COLD DISPOSABLE PACK

Device Problem Insufficient Information (3190)

Patient Problems Rash (2033); Superficial (First Degree) Burn (2685)

Event Date 07/01/2023

Event Type  Injury  

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 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 of the product.A risk calculation cannot be determined as there is no reasonable suggestion of a device malfunction.

Event Description

On 17-jul-2023, a spontaneous report from the united states was received via email regarding a female consumer (age not provided) who used an unspecified thermacare heat wrap.On an unspecified date in (b)(6) 2023, the consumer topically applied a thermacare heat wrap for her sciatica.After wearing the product just over an hour, the heat wrap burnt her skin.She had blisters that had droplets of water in them.The next day upon awakening, she had a rash with blisters.

• Brand Name: THERMACARE HEAT WRAP
• Type of Device: HOT OR COLD DISPOSABLE PACK
• Manufacturer (Section D): BRIDGES CONSUMER HEALTHCARE; 811 broad street, suite 600; chattanooga TN 37402
• Manufacturer (Section G): ANGELINI PHARMA; 1231 wyandotte dr; albany GA 31705
• Manufacturer Contact: 1231 wyandotte dr; albany, GA 31705
• MDR Report Key: 17447184
• MDR Text Key: 320284998
• Report Number: 3007593958-2023-00042
• 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: 07/28/2023

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
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 07/17/2023
• Initial Date FDA Received: 08/02/2023
• Was Device Evaluated by Manufacturer?: No
• 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