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

Device Problem Insufficient Information (3190)

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

Event Type  malfunction  

Event Description

On (b)(6).2023, a spontaneous report from the united states was received regarding a female (age not provided) that was in the possession of a box of thermacare neck/shoulder/wrist 8hr heat wraps.The consumer noted in one box of thermacare neck/shoulder/wrist 8hr heat wraps there was a couple of heat wraps which the heat cells were exposed.This is the first case for the noted "couple" of heat wraps (see (b)(4).For the second case).The consumer declined to provide additional information.

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 heat cells damaged leaking.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 heat cells damaged leaking and a risk calculation cannot be determined as there is no known batch number to identify if there were a device malfunction.

• 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: 18384277
• MDR Text Key: 331302753
• Report Number: 3007593958-2023-00080
• 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: 12/19/2023

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
• Initial Date Manufacturer Received: 11/29/2023
• Initial Date FDA Received: 12/22/2023
• 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