BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TITAN OTR

    MDR report key: 16312543 · Received February 7, 2023

    Report

    Report Number
    2125050-2023-00137
    Event Type
    Injury
    Date Received
    February 7, 2023
    Date of Event
    October 2, 2022
    Report Date
    February 20, 2023
    Manufacturer
    COLOPLAST A/S
    Product Code
    FHW
    PMA / PMN Number
    P000006
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE LOT NUMBER 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.

    Additional Manufacturer Narrative · 0

    CORRECTION: MEDICAL DEVICE NAME, COMMON DEVICE NAME, ITEM NUMBER, CATALOGUE NUMBER, LOT NUMBER, UDI NUMBER CORRECTION: MEDICAL DEVICE PROBLEM CODE: A24 CHANGED TO A040503 - MATERIAL EROSION. CLINICAL SIGN AND SYMPTOMS CODE: E2006 CHANGED TO E2403 - OTHERS-NO CLINICAL SIGNS, SYMPTOMS OR CONDITIONS. THE LOT NUMBER WAS REVIEWED FOR COMPLAINT TREND, NONCONFORMING REPORT AND CAPA. DEVICES MET SPECIFICATION PRIOR TO RELEASE AND NO TRENDS WERE NOTED.

    Description of Event or Problem · 0

    ACCORDING TO AVAILABLE INFORMATION, THIS DEVICE REQUIRED REPLACEMENT DUE TO EROSION. THE TUBES WERE ERODED. IT WAS NOTED THAT THE BASE OF THE LEFT CYLINDER WAS CUT TO FIT INTO THE PATIENT. NO OTHER ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    114403 TITAN OTR TITAN OTR SCROTAL 18CM FHW COLOPLAST A/S QSR9181022 1837422R

    Patients

    Seq Age Sex Outcome Treatment
    1 42 YR Male Required Intervention| H