BEUDAMED
    FDA Adverse Event Other Summary report: N

    LAUFE DIVERGENT OUTLET FORCEPS

    MDR report key: 259175 · Received January 19, 2000

    Report

    Report Number
    1423507-2000-00017
    Event Type
    Other
    Date Received
    January 19, 2000
    Report Date
    January 19, 2000
    Manufacturer
    ALLEGIANCE HEALTHCARE CORP.
    Product Code
    HDA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    THE PSEUDOFENESTRATIONS ARE EXCESSIVELY SHARP AT THEIR MARGINS AND HAVE CAUSED UNNECESSARY FACIAL BRUISING AND ABRASIONS ON SEVERAL OCCASIONS. IN ADDITION, THE CEPHALIC CURVE OF THE INSTRUMENT HAS EXCESSIVE "TOEING" OF THE INFERIOR ASPECT OF THE BLADE, RESULTING IN UNEVEN DISTRIBUTION OF FORCE AGAINST THE FETAL HEAD, WHICH ALSO CONTRIBUTES TO FACIAL BRUISING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LAUFE DIVERGENT OUTLET FORCEPS INSTRUMENT HDA ALLEGIANCE HEALTHCARE CORP. GL5630 R

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other