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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BELMONT INSTRUMENT LLC CRITICOOL THERMAL REGULATING SYSTEMS

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BELMONT INSTRUMENT LLC CRITICOOL THERMAL REGULATING SYSTEMS Back to Search Results
Device Problem Appropriate Term/Code Not Available (3191)
Patient Problem Skin Inflammation (2443)
Event Date 08/29/2018
Event Type  malfunction  
Manufacturer Narrative
The data retrieved from the device showed that there was a higher surface temperature than core temperature, which could indicate that the heating lamp was on while cooling. The data also showed an elevated line pressure, which could indicate that the wrap was too tight on the patient.
 
Event Description
On (b)(6) 2018, the doctor at the user facility reported that a patient was exhibiting signs of subcutaneous fat necrosis and was removed from the criticool prior to the completion of a 72 hour treatment.
 
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Brand NameCRITICOOL
Type of DeviceTHERMAL REGULATING SYSTEMS
Manufacturer (Section D)
BELMONT INSTRUMENT LLC
780 boston road
billerica MA 01821
Manufacturer (Section G)
BELMONT INSTRUMENT LLC
780 boston road
billerica MA 01821
Manufacturer Contact
sabrina belladue
780 boston road
billerica, MA 01821
9783307637
MDR Report Key7920765
MDR Text Key124364516
Report Number1219702-2018-00034
Device Sequence Number1
Product Code DWJ
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K071341
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation
Type of Report Initial
Report Date 09/28/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received09/28/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received08/29/2018
Was Device Evaluated by Manufacturer? Yes
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unkown

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