BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TITAN OTR

    MDR report key: 14567173 · Received June 1, 2022

    Report

    Report Number
    2125050-2022-00572
    Event Type
    Injury
    Date Received
    June 1, 2022
    Date of Event
    May 15, 2022
    Report Date
    August 8, 2022
    Manufacturer
    COLOPLAST A/S
    Product Code
    FHW
    PMA / PMN Number
    P000006
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    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. THE LOT NUMBER (5924846) WAS REVIEWED FOR COMPLAINT TREND, NONCONFORMING REPORT AND CAPA. DEVICES MET SPECIFICATION PRIOR TO RELEASE AND NO TRENDS WERE NOTED.

    Additional Manufacturer Narrative · 0

    TITAN OTR PUMP AND CYLINDERS 1 AND 2 WERE RECEIVED FOR EVALUATION. ABRASION WAS NOTED ON BOTH EXHAUST TUBES AND THE INLET TUBE OF THE PUMP. NO FUNCTIONAL ABNORMALITIES WERE NOTED WITH THE PUMP. ABRASION WAS NOTED ON THE EXHAUST TUBING OF CYLINDER 1 AND CYLINDER 2. NO FUNCTIONAL ABNORMALITIES WERE NOTED WITH CYLINDER 1 OR CYLINDER 2. THE INFORMATION RECEIVED INDICATED THE DEVICE HAD A LEAK IN THE SYSTEM, BUT BECAUSE NO FUNCTIONAL ABNORMALITIES WERE NOTED WITH THE RETURNED COMPONENTS, THE COMPLAINT COULD NOT BE CONFIRMED AS REPORTED. A REVIEW OF THE DEVICE HISTORY RECORD CONFIRMED THE DEVICES FROM THIS LOT MET ALL SPECIFICATIONS PRIOR TO RELEASE. A REVIEW OF THE COMPLAINT HISTORY DATABASE, NONCONFORMANCES AND CAPAS REVEALED NO TRENDS FOR THIS LOT.

    Description of Event or Problem · 0

    ACCORDING TO AVAILABLE INFORMATION, THIS DEVICE WAS EXPLANTED AND REPLACED DUE TO LEAKAGE NOTED AT THE PUMP INLET TUBE. NO OTHER ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1731672 TITAN OTR INFLATABLE PENILE PROSTHESIS FHW COLOPLAST A/S QNR9181022 5924846

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Male Required Intervention