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

Lot Number 23H230

Device Problem Insufficient Information (3190)

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

Event Date 02/03/2024

Event Type  malfunction  

Event Description

On (b)(6)2024, a spontaneous report from the united states was received via email regarding a female (age not provided) who used a thermacare neck/shoulder/wrist heat wrap.On (b)(6)2024, the patient topically applied a thermacare neck/shoulder/wrist heat wrap near her stomach area.After applying the heat wrap, she noted the bottom of the wrap was open.She noted that some of the black heating elements went inside her underwear.The stated that the sticky part at the edges would not stick.The consumer declined to provide additional information.

Manufacturer Narrative

The consumer stated "that some of the black heating elements went inside her underwear." the site completed a preliminary investigation for 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.There are pre-identified risk factors that could cause a heat cell contents to leak listed in the hazard analysis (rpt-000097160) and precautions are taken within the manufacturing process to mitigate those risks.This is not an adverse event as the consumer did not receive an adverse reaction.The return sample was received at the site on (b)(6) 2024.Therefore, the final investigation is still in process.Once the final investigation has been completed an updated fda mdr quality data form will be submitted.The risk calculation will be included in the final investigation.

• Brand Name: THERMACARE NECK/SHOULDER/WRIST
• Type of Device: HOT OR COLD DISPOSABLE PACK.
• Manufacturer (Section D): BRIDGES CONSUMER HEALTHCARE; 1231 wyandotte dr; chattanooga TN 37402
• Manufacturer (Section G): ANGELINI; 1231 wyandotte dr; albany GA 31705
• Manufacturer Contact: rebecca ethrdige ; 1231 wyandotte dr; albany, GA 31705 ; 2294463085
• MDR Report Key: 18817349
• MDR Text Key: 337739462
• Report Number: 3007593958-2024-00012
• 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: 02/27/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/01/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Lot Number: 23H230
• Date Manufacturer Received: 02/05/2024
• 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