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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: COOK MEDICAL, LLC/ COOK VANDERGRIFT INC COOK-SWARTZ DOPPLER PROBE, STANDARD CUFF TRANSDUCER, ULTRASONIC, DIAGNOSTIC

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COOK MEDICAL, LLC/ COOK VANDERGRIFT INC COOK-SWARTZ DOPPLER PROBE, STANDARD CUFF TRANSDUCER, ULTRASONIC, DIAGNOSTIC Back to Search Results
Model Number G21363
Device Problem Material Separation (1562)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 02/06/2019
Event Type  malfunction  
Event Description
Doppler was placed with no issues; six days afterward it was removed. Removal done per manufacturer instructions; however, tip of wire was noted to be separated/broken. No plan to retrieve wire from patient, no harm to patient. Fda safety report id #: (b)(4).
 
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Brand NameCOOK-SWARTZ DOPPLER PROBE, STANDARD CUFF
Type of DeviceTRANSDUCER, ULTRASONIC, DIAGNOSTIC
Manufacturer (Section D)
COOK MEDICAL, LLC/ COOK VANDERGRIFT INC
MDR Report Key8503810
MDR Text Key141748245
Report NumberMW5085771
Device Sequence Number0
Product Code ITX
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Risk Manager
Type of Report Initial
Report Date 04/08/2019
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received04/10/2019
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberG21363
Device Catalogue NumberG21363
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No Answer provided
Was the Report Sent to FDA?
Event Location No Information
Was Device Evaluated by Manufacturer?
Is the Device Single Use?
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

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