BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EXETER INTRODUCER EXTRACTOR

    MDR report key: 46241 · Received October 21, 1996

    Report

    Report Number
    2219689-1996-90004
    Event Type
    Malfunction
    Date Received
    October 21, 1996
    Report Date
    October 18, 1996
    Manufacturer
    HOWMEDICA INC
    Product Code
    LZV
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    THE DEVICE LEAKS. THE LIQUID COMES OUT OF THE THREAD. THIS EVENT DID NOT CAUSE ANY ADVERSE CONSEQUENCE TO THE PT OR DELAY IN SURGICAL OR ANESTHESIA TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EXETER INTRODUCER EXTRACTOR INSTRUMENT LZV HOWMEDICA INC NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other