BEUDAMED
    FDA Adverse Event Injury Summary report: N

    (2BO)TITAN OTR SCROTAL 22CM

    MDR report key: 7948020 · Received October 9, 2018

    Report

    Report Number
    2125050-2018-00729
    Event Type
    Injury
    Date Received
    October 9, 2018
    Date of Event
    September 10, 2018
    Report Date
    October 9, 2018
    Manufacturer
    COLOPLAST A/S
    Product Code
    FHW
    PMA / PMN Number
    P000006
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    QUALITY WAS UNSUCCESSFUL IN SECURING THE DEVICE FOR EVALUATION. WITHOUT THE BENEFIT OF ANALYZING THE DEVICE, QUALITY CANNOT CONFIRM ANY OBSERVATIONS AND CANNOT COMMENT ON THE CONDITION OF THE DEVICE. QUALITY REVIEWED THE MANUFACTURING RECORDS FOR THIS DEVICE AND CONFIRMED THAT THERE WERE NO DISCREPANCIES THAT WOULD HAVE CONTRIBUTED TO THIS COMPLAINT AND VERIFIED THAT THE DEVICES FROM THIS LOT MET ALL SPECIFICATIONS PRIOR TO RELEASE. REVIEW OF NONCONFORMING REPORTS REVEALED NO NONCONFORMANCE WITH THIS LOT THAT WOULD HAVE CONTRIBUTED TO THE EVENT. A REVIEW OF THE COMPLAINT DATABASE REVEALED NO SIGNIFICANT TRENDS IN COMPLAINTS OF THIS TYPE FOR LOT 1911131. THE MOST LIKELY ROOT CAUSE OF THE EVENT CANNOT BE DETERMINED AT THIS TIME. IF THE DEVICE OR ADDITIONAL INFORMATION IS RECEIVED, QUALITY WILL RE-EVALUATE THIS EVENT IN ACCORDANCE WITH PROCEDURES.

    Description of Event or Problem · 1

    ACCORDING TO THE AVAILABLE INFORMATION, TUBING FRAYED/BROKE NEAR RIGHT CYLINDER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    789201 (2BO)TITAN OTR SCROTAL 22CM INFLATABLE PENILE PROSTHESIS FHW COLOPLAST A/S QSR9221400 1911131

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Other