BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TITAN TOUCH

    MDR report key: 13726351 · Received March 10, 2022

    Report

    Report Number
    2125050-2022-00224
    Event Type
    Malfunction
    Date Received
    March 10, 2022
    Date of Event
    February 24, 2022
    Report Date
    April 11, 2022
    Manufacturer
    COLOPLAST A/S
    Product Code
    FHW
    UDI-DI
    05708932539197
    PMA / PMN Number
    P000006
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    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 (8091616) WAS REVIEWED FOR COMPLAINT TREND, NONCONFORMING REPORT AND CAPA. DEVICES MET SPECIFICATION PRIOR TO RELEASE AND NO TRENDS WERE NOTED.

    Additional Manufacturer Narrative · 0

    A TITAN TOUCH PUMP AND TWO CYLINDERS WERE RECEIVED FOR EVALUATION. AS EXAMINATION OF THE COMPONENTS MAY NOT CONCLUSIVELY CONFIRM OR DISPROVE THE REPORT OF FOREIGN MATERIAL, QUALITY ACCEPTS THE PHYSICIAN¿S OBSERVATIONS AS TO THE REASON FOR 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 AVAILABLE INFORMATION, THE PACKAGED DEVICE WHEN OPENED, WAS OBSERVED TO HAVE A DARK HAIR STUCK TO ONE OF THE CYLINDERS. NO ADVERSE PATIENT EFFECTS WERE REPORTED AS THE DEVICE WAS NOT USED ON A PATIENT.

    Description of Event or Problem · 0

    A TITAN TOUCH PUMP AND TWO CYLINDERS WERE RECEIVED FOR EVALUATION. AS EXAMINATION OF THE COMPONENTS MAY NOT CONCLUSIVELY CONFIRM OR DISPROVE THE REPORT OF FOREIGN MATERIAL, QUALITY ACCEPTS THE PHYSICIAN¿S OBSERVATIONS AS TO THE REASON FOR 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.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2269708 TITAN TOUCH INFLATABLE PENILE PROSTHESIS FHW COLOPLAST A/S ES29202400 8091616 05708932539197

    Patients

    Seq Age Sex Outcome Treatment
    1 37 YR Male