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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 INFANT CUREWRAP
Device Problem Fluid/Blood Leak (1250)
Patient Problems No Information (3190); No Clinical Signs, Symptoms or Conditions (4582)
Event Type  malfunction  
Manufacturer Narrative
The wrap has not been returned to belmont for evaluation. We have reached out to the user facility 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 an infant curewrap was leaking at the plastic connection side of the blanket.
 
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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 Key10047512
MDR Text Key190662465
Report Number1219702-2020-00037
Device Sequence Number1
Product Code DWJ
UDI-Device Identifier07290012127182
UDI-Public07290012127182
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K083662
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type User Facility,Company Representative
Reporter Occupation Non-Healthcare Professional
Type of Report Initial,Followup
Report Date 05/11/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received05/12/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberINFANT CUREWRAP
Device Catalogue Number500-03518
Device Lot NumberM192481
Was Device Available for Evaluation? No
Date Manufacturer Received04/16/2020
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured09/05/2019
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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