BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALTIS

    MDR report key: 10919174 · Received November 27, 2020

    Report

    Report Number
    MW5098132
    Event Type
    Malfunction
    Date Received
    November 27, 2020
    Date of Event
    November 24, 2020
    Report Date
    November 24, 2020
    Manufacturer
    COLOPLAST A/S HOLTEDAM / COLOPLAST MANUFACTURING US, LLC
    Product Code
    PAH
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CA, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    DURING BLADDER SLING INSERTION OF PRODUCT ALTIS BATCH CODE 7203149, CATALOG NUMBER 5196502400. ITEM WAS BROKE WHEN SURGEON WENT TO PLACE SLING. FDA SAFETY REPORT ID # (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1380262 ALTIS MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC, FOR STRESS URINARY INCONTINENCE, FEMA PAH COLOPLAST A/S HOLTEDAM / COLOPLAST MANUFACTURING US, LLC 7203149

    Patients

    Seq Age Sex Outcome Treatment
    1 40 YR