BEUDAMED
    FDA Adverse Event Injury Summary report: N

    A PLUS INTERNATIONAL INC.

    MDR report key: 8570631 · Received May 1, 2019

    Report

    Report Number
    1047429-2019-00006
    Event Type
    Injury
    Date Received
    May 1, 2019
    Date of Event
    April 5, 2019
    Report Date
    May 1, 2019
    Manufacturer
    A PLUS INTERNATIONAL INC
    Product Code
    GDY
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    AVID MEDICAL IS THE MANUFACTURER OF A CUSTOM PROCEDURE TRAY, ADCO025-22 - GENERAL LAPAROSCOPY PACK THAT INCLUDES THE FOLLOWING COMPONENT: GAUZE, 4 X 4 16PLY XR , VENDOR PART # GS-4416-7S MANUFACTURED BY A PLUS INTERNATIONAL INC. AVID MEDICAL RECEIVED COMPLAINT ON (B)(6) 2019 ORIGINATED BY DEBRA BOL AT CONDELL MEDICAL CENTER STATING THAT A BLUE RADIOPAQUE STRING IN THE RAYTEC SPONGE DETACHED FROM GAUZE WHILE INSIDE THE PATIENT DURING A LAPAROSCOPIC CASE. THE COMPLAINT COMPONENT WAS NOT AVAILABLE FOR EVALUATION, HOWEVER A PHOTO WAS AVAILABLE. AVID MEDICAL ISSUED FORMAL COMPLAINT # 190400036 TO THE MANUFACTURER A PLUS INTERNATIONAL INC. NO PATIENT INJURY WAS REPORTED, AND NO ADDITIONAL TREATMENT WAS REQUIRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    361560 A PLUS INTERNATIONAL INC. GAUZE SPONGE, INTERNAL, X-RAY DETECTABLE GDY A PLUS INTERNATIONAL INC GS-4416-7S 109081

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention