BEUDAMED
    FDA Adverse Event Injury Summary report: N

    18 X 18 X R 5S NO RING

    MDR report key: 5996397 · Received September 30, 2016

    Report

    Report Number
    MW5065156
    Event Type
    Injury
    Date Received
    September 30, 2016
    Date of Event
    September 28, 2016
    Report Date
    September 30, 2016
    Manufacturer
    US MEDCO, INC.
    Product Code
    GDY
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    IL, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    DURING A SURGICAL PROCEDURE ON SEPTEMBER 28, THE BLUE X-RAY DETECTABLE [INVALID] ATTACHED TO THE LAP SPONGES CAME OFF DURING THE SURGERY, THERE WERE 5 LAP SPONGES AND ALL 5 BLUE [INVALID] CAME OFF. THE SURGICAL TEAM WAS ABLE TO RETRIEVE ALL PARTS, THE ITEMS WERE REMOVED FROM THE SURGICAL FIELD AND SEQUESTERED. DATES OF USE: (B)(6) 2016. DIAGNOSIS OR REASON FOR USE: BELOW KNEE AMPUTATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    643303 18 X 18 X R 5S NO RING 18 X 18 X R 5S NO RING GDY US MEDCO, INC.
    643304 18 X 18 X R 5S NO RING 18 X 18 X R 5S NO RING GDY US MEDCO, INC.
    643305 18 X 18 X R 5S NO RING 18 X 18 X R 5S NO RING GDY US MEDCO, INC.
    643306 18 X 18 X R 5S NO RING 18 X 18 X R 5S NO RING GDY US MEDCO, INC. 05/01/2019
    643307 18 X 18 X R 5S NO RING 18 X 18 X R 5S NO RING GDY US MEDCO, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 47 YR Required Intervention