BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PREMIERPRO

    MDR report key: 10612641 · Received October 1, 2020

    Report

    Report Number
    10612641
    Event Type
    Malfunction
    Date Received
    October 1, 2020
    Date of Event
    September 8, 2020
    Report Date
    September 8, 2020
    Manufacturer
    SVS LLC
    Product Code
    GDY
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    VA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    PACK OF LAPS BY PREMIERE PRO HAD 6 LAPS. LAPS AND PACKAGING NOT SAVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1078812 PREMIERPRO GAUZE/SPONGE, INTERNAL, X-RAY DETECTABLE GDY SVS LLC X8435 CBJ03-07

    Patients

    Seq Age Sex Outcome Treatment
    1 23360 DA