BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 366326 · Received December 12, 2001

    Report

    Report Number
    2648188-2001-00039
    Event Type
    Malfunction
    Date Received
    December 12, 2001
    Report Date
    November 12, 2001
    Manufacturer
    MANATI - USS
    Product Code
    GAM
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    DENTIST

    Narratives

    Description of Event or Problem · 1

    ALLEGEDLY THE NEEDLES ARE BREAKING AND DETACHING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    56110 DEX II BE 1X18 CE2 4/0 N/S BRAIDED SYNTHETIC ABSORBABLE SUTURE GAM MANATI - USS NA 980815

    Patients

    Seq Age Sex Outcome Treatment
    1 *