BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PDS #1 SUTURE ETHICON

    MDR report key: 155998 · Received March 12, 1998

    Report

    Report Number
    MW1013144
    Event Type
    Malfunction
    Date Received
    March 12, 1998
    Date of Event
    November 11, 1997
    Report Date
    February 13, 1998
    Manufacturer
    ETHICON INC.
    Product Code
    GAN
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    A 69 YR OLD FEMALE ADMITTED FOR EXPLORATORY LAPAROTOMY. 7 DAYS POST SURGERY (11/11/97), WOUND DEHISED. TAKEN BACK TO SURGERY FOR REPAIR OF WOUND DEHISCENSE. SUTURE PDS #1 BY ETHICON BROKE APPARENTLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PDS #1 SUTURE ETHICON Implant SUTURE GAN ETHICON INC. PDS #1 *

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Other