BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PDS II (POLYDIOXANONE) SUTURE

    MDR report key: 52301 · Received November 21, 1996

    Report

    Report Number
    2210968-1996-00035
    Event Type
    Injury
    Date Received
    November 21, 1996
    Date of Event
    October 19, 1996
    Report Date
    November 21, 1996
    Manufacturer
    ETHICON, INC.
    Product Code
    GAN
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    SUTURE BREAKAGE POST-OP. RE-OP TO REPAIR DEHISCENCE 36 HOURS AFTER ABDOMINAL AORTIC ANEURYSM SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PDS II (POLYDIOXANONE) SUTURE Implant ABSORBABLE SUTURE GAN ETHICON, INC. NA JH2592

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Required Intervention