BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DEX S BE 1X18 CE2 4/0 N/S

    MDR report key: 391326 · Received April 26, 2002

    Report

    Report Number
    2648188-2002-00047
    Event Type
    Malfunction
    Date Received
    April 26, 2002
    Report Date
    March 27, 2002
    Manufacturer
    MANATI - USS
    Product Code
    GAN
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    REPORTEDLY 8-12 DAYS AFTER A BUNION PROCEDURE THE PTS EXPERIENCED DEHISCENCE. THE DOCTOR DID NOT KNOW WHETHER THE SUTURES BROKE OR THE KNOTS BECAME LOOSE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DEX S BE 1X18 CE2 4/0 N/S ABSORBABLE SYNTHETIC SUTURE GAN MANATI - USS NA 965537

    Patients

    Seq Age Sex Outcome Treatment
    1 *