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

Model Number	CUREWRAP
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The curewrap has not been returned to belmont for evaluation.A review of the video provided by the user facility indicates a leak in the connecting hose.However, without evaluating the wrap it is difficult to determine the cause of the leak.A review of complaints for the past three years indicates that there have been no additional complaints related to this lot number.The operator's manual informs the user, "if moisture or leaks are discovered in the connecting hose and/or wrap, turn off the criticool device, disconnect the power cable from its power source, and correct the problem before proceeding." no patient injury was reported.We will continue to monitor and trend similar reports of this nature and take further action if required.Should additional information become available, a supplemental report will be submitted.
Event or Problem Description
The customer reported that the curewrap was leaking.

• Brand Name: CRITICOOL
• Common Device Name: THERMAL REGULATING SYSTEM
• Manufacturer (Section D): BELMONT MEDICAL TECHNOLOGIES; 780 boston road; billerica, ma
• MDR Report Key: 10417687
• Report Number: 1219702-2020-00060
• Device Sequence Number: 16941445
• Product Code: DWJ
• UDI-Device Identifier: 17290012127172
• UDI-Public: 17290012127172
• Combination Product (Y/N): N
• Initial Reporter Country: HK
• PMA/510(K) Number: K083662
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,user facility
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 08/14/2020

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
• Operator of Device: Health Professional
• Device Model Number: CUREWRAP
• Device Catalogue Number: 508-03500
• Device Lot Number: M192521
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/16/2020
• Initial Report FDA Received Date: 08/17/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1