BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ANGIO-SEAL

    MDR report key: 213523 · Received March 4, 1999

    Report

    Report Number
    3032312-1999-00050
    Event Type
    Injury
    Date Received
    March 4, 1999
    Date of Event
    February 1, 1999
    Report Date
    February 1, 1999
    Manufacturer
    THE KENDALL CO.
    Product Code
    MGB
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    ON 02/01/1999 FOLLOWING A DIAGNOSTIC PROCEDURE AN ANGIO-SEAL DEVICE WAS PLACED IN A PT'S RIGHT GROIN. REPORTEDLY THE DEVICE DEPLOYMENT WAS UNEVENTFUL. THE PT WAS ON BED REST FOR FIVE HOURS POST DEPLOYMENT WHEN WHILE SITTING UP AND BENDING FORWARD, SHE HEARD A POPPING SOUND AND AN IMMEDIATE BLEED WAS NOTED. MANUAL PRESSURE WAS HELD (DURATION UNK) AND HEMOSTASIS ACHIEVED. THE RIGHT LEG WAS NOTED TO BE COOLER THAN THE LEFT, WITH DIMINISHED PULSES. A SURGERY CONSULT AND ULTRASOUND WERE OBTAINED, WITH THE SURGEON CONCLUDING THAT SURGERY WAS NOT INDICATED AT THAT TIME; HOWEVER, ON 02/02/1999 SURGERY WAS PERFORMED AND THE DEVICE REMOVED. THE PT WAS RECOVERING AND WAS TO BE DISCHARGED THE NEXT DAY. AS OF 03/01/1999 THERE HAS BEEN NO FURTHER REPORT TO THE MFR OF COMPLICATION OR ADDITIONAL PT SEQUELAE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ANGIO-SEAL Implant HEMOSTATIC PUNCTURE CLOSURE DEVICE MGB THE KENDALL CO. NA 100780

    Patients

    Seq Age Sex Outcome Treatment
    1 NO INFO Hospitalization| R