BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 369644 · Received December 28, 2001

    Report

    Report Number
    2648188-2001-00042
    Event Type
    Malfunction
    Date Received
    December 28, 2001
    Report Date
    November 30, 2001
    Manufacturer
    MANATI - USS
    Product Code
    GAN
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SN
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    REPORTEDLY THE SUTURE BROKE OFF.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    58862 DEX II BE 1X18 CE2 4/0 N/S ABSORBABLE SYNTHETIC SUTURE GAN MANATI - USS NA 4000050044

    Patients

    Seq Age Sex Outcome Treatment
    1 *