BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PREMIERPRO

    MDR report key: 19212480 · Received April 30, 2024

    Report

    Report Number
    19212480
    Event Type
    Malfunction
    Date Received
    April 30, 2024
    Date of Event
    February 1, 2024
    Report Date
    February 12, 2024
    Manufacturer
    SVS LLC
    Product Code
    KKX
    UDI-DI
    00818566010193
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    VA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    FOREIGN OBJECT IN STERILE PACKAGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    170948 PREMIERPRO DRAPE, SURGICAL KKX SVS LLC 8326B CBBM09-01 00818566010193

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown