BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-SORB XRAY DETECTABLE USP TYPE VII GAUZE

    MDR report key: 3226054 · Received June 21, 2013

    Report

    Report Number
    3226054
    Event Type
    Malfunction
    Date Received
    June 21, 2013
    Date of Event
    June 12, 2013
    Report Date
    June 21, 2013
    Manufacturer
    MEDLINE INC.
    Product Code
    GDY
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    SC, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    DURING THE SURGICAL SET UP, THE SCRUB TECH OBSERVED THE RAYTEC SPONGE THREADS FRYING APART. THE SPONGES WERE REMOVED FROM THE STERILE SET UP BEFORE SURGERY. NO HARM TO THE PATIENT. TWO PACKAGES FROM DIFFERENT LOT NUMBERS WERE INVOLVED IN THIS EVENT.======================MANUFACTURER RESPONSE FOR RAYTEC SPONGE, ACCU-SORB XRAYDETECTABLE USP TYPE VII GAUZE (PER SITE REPORTER).======================NOT KNOWN BY THE REPORTER.WHAT WAS THE ORIGINAL INTENDED PROCEDURE?NA.DEVICE #1IS THIS A LABORATORY DEVICE OR LABORATORY TEST?NO.DEVICE #2IS THIS A LABORATORY DEVICE OR LABORATORY TEST?NO.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    281985 ACCU-SORB XRAY DETECTABLE USP TYPE VII GAUZE SPONGE, GAUZE GDY MEDLINE INC. * AR4506229277
    281986 ACCU-SORB XRAY DETECTABLE USP TYPE VII GAUZE SPONGE, GAUZE GDY MEDLINE INC. * AR4506107115

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR