BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TITAN TOUCH

    MDR report key: 12648372 · Received October 18, 2021

    Report

    Report Number
    2125050-2021-01501
    Event Type
    Injury
    Date Received
    October 18, 2021
    Report Date
    December 17, 2021
    Manufacturer
    COLOPLAST A/S
    Product Code
    FHW
    UDI-DI
    05708932533966
    PMA / PMN Number
    P000006
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    A TITAN TOUCH PUMP, RESERVOIR, AND BOTH CYLINDERS WERE RECEIVED FOR EVALUATION. AS EXAMINATION OF THE COMPONENTS MAY NOT CONCLUSIVELY CONFIRM OR DISPROVE THE REPORT OF EROSION, QUALITY ACCEPTS THE PHYSICIAN¿S OBSERVATIONS AS TO THE REASON FOR SURGICAL INTERVENTION. 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 THE AVAILABLE INFORMATION THE TITAN TOUCH WAS IMPLANTED ON (B)(6) 2018 AND REVISED ON (B)(6) 2021 DUE TO EROSION/EXTRUSION. ADDITIONAL INFORMATION RECEIVED INDICATED THAT THE PATIENT NEVER INFLATED THEIR DEVICE THE ENTIRE TIME THAT THEY HAD IT. IT HAD ERODED AND EXTRUDED THROUGH THE LEFT SIDE DISTALLY.

    Additional Manufacturer Narrative · 1

    COLOPLAST HAS NOT BEEN PROVIDED ANY CORROBORATING EVIDENCE TO VERIFY THE INFORMATION CONTAINED IN THIS REPORT.

    Description of Event or Problem · 1

    AS REPORTED TO COLOPLAST, THOUGH NOT VERIFIED, PATIENT WAS EXPERIENCING EROSION/EXTRUSION. THE PATIENT'S TITAN TOUCH WAS EXPLANTED AND REPLACED WITH A GENESIS. ADDITIONAL INFORMATION RECEIVED THAT THE PATIENT NEVER DEFLATED THE DEVICE THE ENTIRE TIME THEY HAD IT. IT ERODED AND EXTRUDED THROUGH ON THE LEFT SIDE DISTALLY. NO OTHER ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1545032 TITAN TOUCH INFLATABLE PENILE PROSTHESIS FHW COLOPLAST A/S 5177502400 6198995 05708932533966

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Male Required Intervention