BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PREMIERPRO

    MDR report key: 12142173 · Received July 9, 2021

    Report

    Report Number
    12142173
    Event Type
    Malfunction
    Date Received
    July 9, 2021
    Date of Event
    June 24, 2021
    Report Date
    June 25, 2021
    Manufacturer
    SVS LLC
    Product Code
    KKX
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    DE
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    DIAGNOSTIC IMAGING ULTRASOUND (DI US) REPORTS THAT WHEN OPENING A NEW BRAND (PREMIER PRO) OF STERILE TOWELS, A DEAD BUG WAS FOUND INSIDE THE STERILE PACKAGING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1042378 PREMIERPRO DRAPE, SURGICAL KKX SVS LLC 8326B CBJ08-01

    Patients

    Seq Age Sex Outcome Treatment
    1