MAUDE Adverse Event Report: BRIDGES CONSUMER HEALTHCARE THERMACARE NECK/SHOULDER/WRIST; HOT OR COLD DISPOSABLE PACK.

Lot Number GA0755

Device Problem Insufficient Information (3190)

Patient Problems Erythema (1840); Pain (1994); Partial thickness (Second Degree) Burn (2694)

Event Date 08/09/2023

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 a burn.The cause of the consumer a burn is inconclusive since review of records does not provide evidence to support defective product.There are pre-identified risk factors that could cause a burn listed in the hazard analysis (rpt-000097160).In addition to these hazards, there are multiple risks that are outside the control of the site.These include things like age, skin condition, medical conditions, device use error and off-label use.The warning labels on our product are used to address these risks and relay the appropriate instructions for use to our customers to avoid burns, blisters and skin irritations.This is an adverse event for a burn and a risk calculation cannot be determined as there is no reasonable suggestion of a device malfunction.

Event Description

On (b)(6) 2023, a spontaneous report from the united states was received via email regarding a female consumer who used a thermacare neck/shoulder/wrist heat wrap.On (b)(6) 2023, the consumer topically applied the heat wrap to her neck.She removed it after 4 hours of use.On (b)(6) 2023, the consumer woke up and noticed redness and pain on her neck.Within about 16 hours of device use, on approximately (b)(6) 2023, the consumer developed burn blisters on her neck.She treated the area with a cold pack and baking soda.The consumer also reported a device use error, as she had applied the wrap directly to her skin.The medical device site erythema, medical device site pain, and burn blisters were ongoing at the time of reporting.Device use error resolved on (b)(6) 2023, as the consumer has not used the device since that date.

• Brand Name: THERMACARE NECK/SHOULDER/WRIST
• 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; 1231 wyandotte dr; albany GA 31705
• Manufacturer Contact: rebecca ethridge ; 1231 wyandotte dr; albany, GA 31705 ; 2294463090
• MDR Report Key: 17628417
• MDR Text Key: 322022183
• Report Number: 3007593958-2023-00052
• 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: 08/23/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/25/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Lot Number: GA0755
• Date Manufacturer Received: 08/10/2023
• Date Device Manufactured: 10/01/2022
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Treatment: HYDRALAZINE
• Patient Outcome(s): Required Intervention
• Patient Age: 69 YR
• Patient Sex: Female
• Patient Weight: 63 KG