BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TITAN

    MDR report key: 10973480 · Received December 9, 2020

    Report

    Report Number
    2125050-2020-01229
    Event Type
    Malfunction
    Date Received
    December 9, 2020
    Report Date
    March 1, 2021
    Manufacturer
    COLOPLAST A/S
    Product Code
    FHW
    PMA / PMN Number
    P000006
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    A TITAN TOUCH PUMP WAS RECEIVED FOR EVALUATION. EXAMINATION AND TESTING OF THE RETURNED COMPONENTS REVEALED NO FUNCTIONAL ABNORMALITIES. A REVIEW OF THE DEVICE HISTORY RECORD CONFIRMED THAT THE DEVICES FROM THIS LOT MET ALL SPECIFICATIONS PRIOR TO RELEASE. A REVIEW OF THE COMPLAINT HISTORY DATABASE, NON-CONFORMANCES AND CAPAS REVEALED NO TRENDS FOR THIS LOT.

    Additional Manufacturer Narrative · 1

    WITHOUT THE BENEFIT OF EXAMINATION AND TESTING, COLOPLAST IS PRECLUDED FROM COMMENTING ON THE CONDITION OF THE DEVICE OR THE CAUSE OF THE OCCURRENCE. ONCE OUR EVALUATION IS COMPLETE, A FOLLOW-UP REPORT WILL BE SUBMITTED. COLOPLAST HAS NOT BEEN PROVIDED ANY CORROBORATING EVIDENCE TO VERIFY THE INFORMATION CONTAINED IN THIS REPORT.

    Description of Event or Problem · 1

    ACCORDING TO THE AVAILABLE INFORMATION, THOUGH NOT VERIFIED, REPORTED COMPLAINT: "THE PUMP IS HARD AND IT IS SLOW TO INFLATE THE PROTHESIS AND TO DEFLATE IS VIRTUALLY IMPOSSIBLE. HE HAS TO USE EXTREME FORCE AND TRY 4 OR 5 TIMES WHICH IS VERY PAINFUL TO DO. IT TAKES AROUND 5 ¿ 10 MINS TO GET IT STARTED TO DEFLATE. WHEN THE PATIENT ARRIVED AT [PHYSICIAN] IT WAS STILL PARTIALLY INFLATED AS HE COULD NOT GET IT DOWN COMPLETELY. [PHYSICIAN] HAS TRIED THE TROUBLESHOOTING TECHNIQUES WITH NO SUCCESS. THE DEVICE WAS REVISED/REPLACED. WILL BE RETURNED. ADDITIONAL INFORMATION RECEIVED 11/15/2020: ONLY THE PUMP WAS REPLACED. ADDITIONAL INFORMATION RECEIVED 11/118/2020: EXPLANTED DEVICE BEING RETURNED. THE LOT # WAS REVIEWED FOR COMPLAINT TREND, NONCONFORMING REPORT AND CAPA. DEVICES MET SPECIFICATION PRIOR TO RELEASE AND NO TRENDS WERE NOTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1442111 TITAN INFLATABLE PENILE PROTHESIS FHW COLOPLAST A/S ES29181022 6401130

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR