MAUDE Adverse Event Report: BELMONT MEDICAL TECHNOLOGIES CUREWRAP; SYSTEM, THERMAL REGULATING

Lot Number M220761

Device Problem Leak/Splash (1354)

Patient Problem Insufficient Information (4580)

Event Date 11/16/2022

Event Type  malfunction  

Event Description

Cooling blanket found to be leaking on upper half by the patient¿s bed.Manufacturer response for induced hypothermia device, curewrap (per site reporter) no report back to date.

• Brand Name: CUREWRAP
• Type of Device: SYSTEM, THERMAL REGULATING
• Manufacturer (Section D): BELMONT MEDICAL TECHNOLOGIES; 780 boston rd.; billerica MA 01821
• MDR Report Key: 15931458
• MDR Text Key: 304969845
• Report Number: 15931458
• Device Sequence Number: 1
• Product Code: DWJ
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 11/28/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/07/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Lot Number: M220761
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 11/28/2022
• Event Location: Hospital
• Date Report to Manufacturer: 12/07/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 4 DA
• Patient Sex: Female
• Patient Weight: 3 KG