BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PREMIERPRO

    MDR report key: 11945988 · Received June 7, 2021

    Report

    Report Number
    11945988
    Event Type
    Malfunction
    Date Received
    June 7, 2021
    Date of Event
    May 14, 2021
    Report Date
    May 25, 2021
    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

    OPENED PACK OF LAPS ONTO STERILE FIELD. WHEN SCRUB TECH OPENED FOLDED LAP COMPLETELY TO GIVE TO SURGEON, SHE FOUND A HAIR INSIDE THE LAP. LAP WAS NEVER PLACED ON/IN THE PATIENT AND WAS THROWN OFF THE FIELD. SURGEON WAS NOTIFIED. LAP SPONGE AND PACKAGING NOT SAVED. MULTIPLE PACKS OF LAP SPONGES OPENED TO STERILE FIELD - UNABLE TO DETERMINE WHICH PACKAGE BELONGED TO CONTAMINATED LAP SPONGES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    842495 PREMIERPRO GAUZE/SPONGE, INTERNAL, X-RAY DETECTABLE GDY SVS LLC X8435

    Patients

    Seq Age Sex Outcome Treatment
    1 16425 DA