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

Lot Number GA0970

Device Problem Insufficient Information (3190)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Type  malfunction  

Manufacturer Narrative

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 a wrap being too hot is inconclusive since review of records does not provide evidence to support defective product.There are pre-identified risk factors that could cause a wrap to be too hot listed in the hazard analysis ((b)(4)).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.These include things like age, skin condition, medical conditions, device use error and off-label use.The warning labels on our product states if product feels too hot - stop use or wear over clothing.This is an adverse event for a wrap too hot and a risk calculation cannot be determined as there is no reasonable suggestion of a device malfunction.

Event Description

On 11-mar-2024, a spontaneous report from the united states was received via email regarding a male (age not provided) who used a thermacare neck/shoulder/wrist heat wrap.On (b)(6) 2024, the consumer topically applied a thermacare neck/shoulder/wrist 8hr heat wrap.Approximately an hour after applying the heat wrap, the consumer noted it was getting too hot to wear.Subsequently, he removed the heat wrap.No additional information was provided.

• 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 ; 2294463085
• MDR Report Key: 19070794
• MDR Text Key: 340570726
• Report Number: 3007593958-2024-00020
• 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: 04/04/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Lot Number: GA0970
• Initial Date Manufacturer Received: 03/11/2024
• Initial Date FDA Received: 04/09/2024
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Sex: Male