BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ETHICON

    MDR report key: 168909 · Received May 22, 1998

    Report

    Report Number
    168909
    Event Type
    Malfunction
    Date Received
    May 22, 1998
    Date of Event
    May 19, 1998
    Report Date
    May 19, 1998
    Manufacturer
    ETHICON, INC. / J & J COMPANY
    Product Code
    GAL
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    NY, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    WHILE DOING MYOMECTOMY SURGERY, MD WAS CLOSING UTERUS WITH ETHICON 2-0 CHRONIC G123H, NEEDLE BROKE IN HALF - LOT# (LCR 327). A SECOND 2-0 CHRONIC G123H WAS USED AND ALSO BROKE IN HALF (LW# LBR 558B) - THIS HALF WAS LODGED IN OPEN UTERUS - LOCATION IDENTIFIED BY X-RAY AND WAS RETRIEVED BY THE SURGEON. WITHOUT CONSEQUENCE TO THE PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ETHICON Implant SH 6123H 2-0 CHROMIC SUTURE GAL ETHICON, INC. / J & J COMPANY 2-0 CHROMIC 27" SH 2-0 CHROMIC LBR558 LCR327

    Patients

    Seq Age Sex Outcome Treatment
    1 28 YR