BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BERKLEY VACUUM CURETTAGE SYSTEM

    MDR report key: 251744 · Received November 23, 1999

    Report

    Report Number
    251744
    Event Type
    Injury
    Date Received
    November 23, 1999
    Date of Event
    September 21, 1999
    Report Date
    October 7, 1999
    Manufacturer
    CABOT MEDICAL CORP.
    Product Code
    HGG
    Report Source
    User Facility report
    Reporter Location
    VA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    DILATION AND EVACUATION MACHINE WAS NOTED TO HAVE LESS SUCTION THAN USUAL DURING A PROCEDURE. THE PT UNDERWENT AN ULTRASOUND WHICH SHOWED A SMALL AMOUNT OF TISSUE REMAINING. THE MACHINE WAS CHECKED, AND IT WAS DISCOVERED THAT THE PLASTIC FILTER HOUSING WAS CRACKED RESULTING IN LESS SUCTION. THIS WAS REPLACED AND VACUUM WAS VERIFIED TO 68 CM OF MERCURY. THE PT RETURNED THE FOLLOWING DAY FOR A REPEAT PROCEDURE. A SMALL AMOUNT OF TISSUE WAS SUCTIONED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BERKLEY VACUUM CURETTAGE SYSTEM DILATION AND EVACUATION MACHINE HGG CABOT MEDICAL CORP. VC2-115VAC60HZ NA

    Patients

    Seq Age Sex Outcome Treatment
    1 28 YR Required Intervention