MAUDE Adverse Event Report: ANGELINI THERMACARE HEAT WRAP; HOT OR COLD DISPOSABLE PACK

Device Problem Insufficient Information (3190)

Patient Problems Scar Tissue (2060); Partial thickness (Second Degree) Burn (2694)

Event Date 10/01/2022

Event Type  Injury  

Manufacturer Narrative

The root cause cannot be identified.There is limited device specific information provided, no batch number or product type description 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 (b)(6) 2022, a spontaneous report was received via social media regarding a female (age not provided) who used a thermacare heat wrap.Medical history and concomitant products were not provided.On an unspecified date on (b)(6) 2022 (reported as two months ago in reference to on (b)(6) 2022) the consumer applied a thermacare heat wrap for an unknown indication.On an unspecified date on (b)(6) 2022, after wearing the heat wrap, the consumer experienced a second degree burn which scared.The consumer noted they used the product as directed.No additional information was provided.

• Brand Name: THERMACARE HEAT WRAP
• 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 ; 4234142221
• MDR Report Key: 16112729
• MDR Text Key: 306844286
• Report Number: 3007593958-2023-00003
• 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: 01/05/2023

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: 12/21/2022
• Initial Date FDA Received: 01/06/2023
• 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
• Patient Sex: Female