BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TITAN OTR

    MDR report key: 4264253 · Received November 3, 2014

    Report

    Report Number
    4264253
    Event Type
    Malfunction
    Date Received
    November 3, 2014
    Date of Event
    October 23, 2014
    Report Date
    November 3, 2014
    Manufacturer
    COLOPLAST MANUFACTURING US, LLC
    Product Code
    FHW
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    TN, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    OPERATIVE REPORT INDICATES THAT DEVICE WOULD NO LONGER INFLATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    703166 TITAN OTR ASSEMBLY PENILE MENTOR FHW COLOPLAST MANUFACTURING US, LLC * *

    Patients

    Seq Age Sex Outcome Treatment
    1 84 YR