BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LEICA MICROSCOPE DRAPE

    MDR report key: 10188690 · Received June 24, 2020

    Report

    Report Number
    10188690
    Event Type
    Malfunction
    Date Received
    June 24, 2020
    Date of Event
    May 28, 2020
    Report Date
    June 1, 2020
    Manufacturer
    PHARMASEPT LTD. MEDICAL PRODUCTS
    Product Code
    KKX
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    VA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    MICROSCOPE DRAPES X2 EACH HAD A RIP AT THE SEAM AT THE OCULAR PIECE. NO PATIENT EXPOSURE OR INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    653714 LEICA MICROSCOPE DRAPE DRAPE, SURGICAL KKX PHARMASEPT LTD. MEDICAL PRODUCTS 9228H 9126490313

    Patients

    Seq Age Sex Outcome Treatment
    1