BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GAUZE/SPONGE, INTERNAL, X-RAY DETECTABLE

    MDR report key: 12057015 · Received June 24, 2021

    Report

    Report Number
    12057015
    Event Type
    Malfunction
    Date Received
    June 24, 2021
    Date of Event
    May 31, 2021
    Report Date
    June 16, 2021
    Manufacturer
    STRYKER CORPORATION
    Product Code
    GDY
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    UT
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    THE STRING OF THE STRYKER SURGICOUNT X-RAY DETECTABLE SAFETY-SPONGE SAFE-T LAP SPONGE (REF# (B)(4), LOT # 0222, EXP. DATE 2023-05-27) FELL OUT DURING SURGICAL/MEDICAL PROCEDURE. SPONGE DID NOT REACH PATIENT AS THE SCRUB TECH NOTICED IT ON THE BACK TABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    958469 GAUZE/SPONGE, INTERNAL, X-RAY DETECTABLE GDY STRYKER CORPORATION 0222

    Patients

    Seq Age Sex Outcome Treatment
    1 1460 DA