BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HUTIV FINAL ASSY, REV, RIGHT

    MDR report key: 2102931 · Received May 4, 2011

    Report

    Report Number
    1518293-2011-00081
    Event Type
    Malfunction
    Date Received
    May 4, 2011
    Date of Event
    April 11, 2011
    Report Date
    April 11, 2011
    Manufacturer
    LIEBEL-FLARSHEIM CO.
    Product Code
    KQS
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PENDING INVESTIGATION. UPON RECEIPT OF INVESTIGATION, A MEDWATCH 3500A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    ON (B)(6): CUSTOMER REPORTED THAT STAFF WAS ATTEMPTING TO PERFORM A UROLOGY PROCEDURE WHEN FLUORO FAILED. PHYSICIAN ABORTED THE PROCEDURE AT THAT TIME AND RESCHEDULED PT PROCEDURE. CUSTOMER REPORTS THE PROCEDURE WAS COMPLETED AT A LATER TIME WITHOUT FURTHER INCIDENT. NO REPORTED INJURY. CUSTOMER WOULD NOT PROVIDE PT OR PROCEDURE INFO WITH REGARDS TO THIS EVENT, EXCEPT TO SAY THE PT IS FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HUTIV FINAL ASSY, REV, RIGHT UROLOGY SUITE KQS LIEBEL-FLARSHEIM CO. HUTIV NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK