BEUDAMED
    FDA Adverse Event Other Summary report: N

    ST. AMNIOTIC PERFORATOR WHITE

    MDR report key: 375350 · Received January 29, 2002

    Report

    Report Number
    1046367-2001-00050
    Event Type
    Other
    Date Received
    January 29, 2002
    Date of Event
    December 18, 2001
    Report Date
    December 24, 2001
    Manufacturer
    DEROYAL INDUSTRIES, INC.
    Product Code
    HGE
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    DR. COMPLAINS THAT THE HOOK IS TOO SHARP AND IS SCRATCHING THE PATIENT'S HEAD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ST. AMNIOTIC PERFORATOR WHITE AMNIOTIC PERFORATOR HGE DEROYAL INDUSTRIES, INC. NA 231771/1B1378

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other