BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TITAN TOUCH

    MDR report key: 12122625 · Received July 6, 2021

    Report

    Report Number
    2125050-2021-00862
    Event Type
    Injury
    Date Received
    July 6, 2021
    Report Date
    August 3, 2021
    Manufacturer
    COLOPLAST A/S
    Product Code
    FHW
    UDI-DI
    05708932539180
    PMA / PMN Number
    P000006
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    D4 LOT NUMBER: 7180865.

    Description of Event or Problem · 0

    ADDITIONAL INFORMATION RECEIVED FURTHER REPORTED THAT UPON EXPLORATION, THE IMPLANT WAS INTACT. THE ISSUE WAS THE LATERAL SIDE OF THE RIGHT-SIDE TUNICA WALL WHERE IT HAD HERNIATED. THERE HAD BEEN A DEFORMED APPEARANCE IN THE SHAFT OF THE PENIS. THE BULGE IN THE TUNICA WALL WAS SUTURED/REPAIRED, AND A NEW CYLINDER WAS IMPLANTED ON THE RIGHT-HAND SIDE.

    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. 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.

    Description of Event or Problem · 1

    ACCORDING TO AVAILABLE INFORMATION, THIS DEVICE WAS EXPLANTED AND REPLACED DUE TO AN UNSPECIFIED DEVICE MALFUNCTION. NO OTHER ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1020417 TITAN TOUCH INFLATABLE PENILE PROSTHESIS FHW COLOPLAST A/S ES29182400 05708932539180

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R