BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TITAN OTR

    MDR report key: 14210784 · Received April 26, 2022

    Report

    Report Number
    2125050-2022-00423
    Event Type
    Injury
    Date Received
    April 26, 2022
    Date of Event
    April 7, 2022
    Report Date
    July 18, 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 (5851614) 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. PARTIAL SEPARATIONS, SURROUNDED BY ABRASION, WERE NOTED ON THE INLET TUBE OF THE PUMP. THESE WERE NOT SITES OF LEAKAGE. A SEPARATION, SURROUNDED BY ABRASION, WAS NOTED ON THE ONE OF THE EXHAUST TUBES OF THE PUMP, NEAR THE STRAIN RELIEF. THIS IS A SITE OF LEAKAGE. NO FUNCTIONAL ABNORMALITIES WERE NOTED WITH EITHER CYLINDER 1 OR CYLINDER 2. BOTH CYLINDERS WERE RETURNED WITH TOW SUTURES ATTACHED. BASED ON EXAMINATION OF THE RETURNED PRODUCT, IT WAS CONCLUDED THAT WHILE IN-VIVO BOTH THE EXHAUST TUBES AND INLET TUBE OF THE PUMP HAD OVERLAPPED AND ABRADED AGAINST ONE ANOTHER. THIS POSITIONING, IN COMBINATION WITH DEVICE USAGE OVER TIME, COULD CONTRIBUTE TO SUFFICIENT STRESS TO SEPARATE ONE OF THE EXHAUST TUBES NEAR THE STRAIN RELIEF. A SEPARATION OF THIS TYPE COULD THEN ALLOW THE LOSS OF FLUID, MAKING THE DEVICE INOPERABLE. 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 PUMP TUBING LEAKAGE NOTED AT THE PUMP EXHAUST TUBE. NO OTHER ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1591136 TITAN OTR INFLATABLE PENILE PROSTHESIS FHW COLOPLAST A/S QNR9181022 5851614

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Male Required Intervention