BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MEDICAL ACTION INDUSTIRES

    MDR report key: 6597786 · Received May 30, 2017

    Report

    Report Number
    9616874-2017-00002
    Event Type
    Malfunction
    Date Received
    May 30, 2017
    Date of Event
    November 30, 2016
    Report Date
    January 9, 2017
    Manufacturer
    JIANGSU PROVINCE JIANERKANG MEDICAL DRESSING CO.,
    Product Code
    GDY
    UDI-DI
    10809160000106
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Additional Manufacturer Narrative · 1

    THE LAP SPONGE RING OR BLUE LOOP ARE USED FOR HELPING DOCTOR TO PULL THE LAP SPONGE OUTSIDE FROM THE ABDOMEN AFTER OPERATION. AFTER OPERATION, THE PATIENT WILL BE TREATED WITH X-RAY SCAN TO CHECK IF ANY FOREIGN COMPONENT LIKE RING OR BLUE LOOP ETC. LEFT INSIDE THE PATIENT'S BODY. LAP SPONGE RING CONTAINS BARIUM SULFATE, AND IT CAN BE VISIBLE UNDER X-RAY, SO EVEN THIS RING LEFT INSIDE THE PATIENT'S BODY, IT CAN BE DETECTED UNDER X-RAY, SO THIS PROBLEM DID NOT RESULT IN SERIOUS INJURY OR DEATH. SO NEED NOT REMEDIAL ACTION FOR THIS PROBLEM.

    Description of Event or Problem · 1

    LAP SPONGE RING DETACHED FROM SPONGE AND WAS DISCOVERED OR SPONGE COUNT AT WHICH TIME IT FELL ONTO THE FLOOR AND WAS RETRIEVED BY OR STAFF. THE SPONGE THEREFORE WAS NOT USED FOR PROCEDURE. THE COMPLAINT LAP SPONGE WAS MEDICAL ACTION INDUSTRIES BRANDED; HOWEVER, THE SPONGES WERE MANUFACTURED BY (B)(4) PROVINCE, JIANERKANG MEDICAL DRESSING CO., LTD OF (B)(4). MW 5066601 WAS RECEIVED FROM FDA FOR THIS OCCURRENCE AS WELL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    379326 MEDICAL ACTION INDUSTIRES LAP SPONGE 18×18 W/XR RING 200/CS GDY JIANGSU PROVINCE JIANERKANG MEDICAL DRESSING CO., 402 1601JK304A 10809160000106

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention