BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TITAN OTR

    MDR report key: 11088933 · Received December 29, 2020

    Report

    Report Number
    2125050-2020-01335
    Event Type
    Malfunction
    Date Received
    December 29, 2020
    Report Date
    December 29, 2020
    Manufacturer
    COLOPLAST A/S
    Product Code
    FHW
    PMA / PMN Number
    P000006
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE LOT # WAS REVIEWED FOR COMPLAINT TREND, NONCONFORMING REPORT AND CAPA. DEVICES MET SPECIFICATION PRIOR TO RELEASE AND NO TRENDS WERE NOTED. WITHOUT THE BENEFIT OF EXAMINATION AND TESTING, COLOPLAST IS PRECLUDED FROM COMMENTING ON THE CONDITION OF THE DEVICE OR THE CAUSE OF THE OCCURRENCE. SHOULD ADDITIONAL FACTS PROMPT US TO ALTER OR SUPPLEMENT ANY INFORMATION OR CONCLUSIONS CONTAINED IN THE ORIGINAL MDR OR IN ANY PRIOR SUPPLEMENTAL REPORTS, A FOLLOW-UP REPORT WILL BE SUBMITTED. LOT NUMBER: 2021920.

    Description of Event or Problem · 1

    ACCORDING TO THE AVAILABLE INFORMATION, THE DEVICE WAS NOT DEFLATING AFTER NINE YEARS OF WORKING. THE DEVICE WAS REMOVED AND REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1553066 TITAN OTR INFLATABLE PENILE PROSTHESIS FHW COLOPLAST A/S QSR9161400

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR