MAUDE Adverse Event Report: ANGELINI THERMACARE NECK/SHOULDER/WRIST 8HR; HOT OR COLD DISPOSABLE PACK.

Lot Number EK9154S

Device Problem Insufficient Information (3190)

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

Event Type  Injury  

Manufacturer Narrative

The root cause cannot be identified.The site investigated this complaint by reviewing the device history records and manufacturing controls.The review of the device history records, batch thermal records, and production controls met the product release criteria.Consumer reports she "experienced second-degree burns which caused scarring".The cause of the consumer stating she received a "second-degree burn with scarring" is inconclusive since review of records does not provide evidence to support defective product.The product effect may vary with each individual.Care should be taken when using the device, following all safety and use information as provided with the wrap to avoid the risks of blisters or other skin irritations.This is an adverse event for a burn and scarring; risk calculation cannot be determined as there is no reasonable suggestion of a device malfunction.

Event Description

On 20-dec-2022, a spontaneous report from the united states was received via email regarding a female (age not provided) who used a thermacare neck/shoulder/wrist 8hr heat wrap.Medical history included pregnancy concurrent with use of the heat wrap.Concomitant products were not provided.On an unspecified date, reported as "well over a year ago" (in reference to 20-dec-2022) the consumer topically applied a thermacare neck/shoulder/wrist 8hr heat wrap for an unknown indication.On an unspecified date, after using the heat wrap, the consumer experienced second-degree burns which caused scarring.The consumer reported she might need surgery to reconstruct.

• Brand Name: THERMACARE NECK/SHOULDER/WRIST 8HR
• 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: 16112713
• MDR Text Key: 306804111
• Report Number: 3007593958-2023-00002
• 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: 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
• Device Expiration Date: 03/31/2024
• Device Lot Number: EK9154S
• Initial Date Manufacturer Received: 12/20/2022
• Initial Date FDA Received: 01/06/2023
• Date Device Manufactured: 04/13/2021
• 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