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U.S. Department of Health and Human Services

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

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BELMONT MEDICAL TECHNOLOGIES CRITICOOL THERMAL REGULATING SYSTEM Back to Search Results
Model Number CUREWRAP
Device Problem Fluid/Blood Leak (1250)
Patient Problem No Information (3190)
Event Type  malfunction  
Manufacturer Narrative
The wrap has not been returned to belmont for evaluation. We have reached out to the distributor to obtain additional information about the case, and to determine whether the wrap is available to be returned for investigation. The operator's manual provides the following warning: "do not lift or move the patient by means of the wrap. This may cause tearing and water leakage from the wrap. " the following precaution is also provided: "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. " without additional information, it is difficult to determine what occurred during the case at this time. Should additional information become available, a supplemental report will be submitted.
 
Event Description
The user facility reported that a curewrap was leaking during a case.
 
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Brand NameCRITICOOL
Type of DeviceTHERMAL REGULATING SYSTEM
Manufacturer (Section D)
BELMONT MEDICAL TECHNOLOGIES
780 boston road
billerica, ma
Manufacturer (Section G)
BELMONT MEDICAL TECHNOLOGIES
780 boston road
billerica, ma
Manufacturer Contact
sabrina belladue
780 boston road
billerica, ma 
3307637
MDR Report Key10014281
MDR Text Key189608175
Report Number1219702-2020-00034
Device Sequence Number1
Product Code DWJ
UDI-Device Identifier07290012127175
UDI-Public07290012127175
Combination Product (y/n)N
Reporter Country CodeTW
PMA/PMN Number
K083662
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type distributor,user facility
Reporter Occupation Non-Healthcare Professional
Type of Report Initial
Report Date 04/30/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received04/30/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberCUREWRAP
Device Catalogue Number508-03500
Device Lot NumberM182051
Was Device Available for Evaluation? No
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received04/01/2020
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unkown

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