BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ETHICON PDS 11 Z346 SUTURE

    MDR report key: 1033404 · Received April 22, 2008

    Report

    Report Number
    MW5006380
    Event Type
    Injury
    Date Received
    April 22, 2008
    Date of Event
    January 17, 2008
    Report Date
    April 22, 2008
    Manufacturer
    ETHICON
    Product Code
    GAN
    Report Source
    Voluntary report
    Reporter Location
    IN, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    WOUND DEHISCENCE 7 DAYS POST OP CESAREAN SECTION. SURGEON FINDINGS: DISSOLUTION OF PDS SUTURE ALONG FASCIAL EDGE WITH NO EVIDENCE OF INFECTION OR "NELLCOSIA".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ETHICON PDS 11 Z346 SUTURE NONE GAN ETHICON * *

    Patients

    Seq Age Sex Outcome Treatment
    1 36 YR Life Threatening