BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TITAN SCROTAL ZERO ANG 18CM

    MDR report key: 8188285 · Received December 20, 2018

    Report

    Report Number
    2125050-2018-00902
    Event Type
    Injury
    Date Received
    December 20, 2018
    Report Date
    February 25, 2019
    Manufacturer
    COLOPLAST A/S
    Product Code
    FHW
    UDI-DI
    05708932487344
    PMA / PMN Number
    P000006
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP MDR IS CREATED TO DOCUMENT THE CONCLUSION OF THE INVESTIGATION. THE DEVICE REMAINS IMPLANTED. WITHOUT THE BENEFIT OF ANALYZING THE DEVICE, QUALITY CANNOT CONFIRM ANY OBSERVATIONS AND CANNOT COMMENT ON THE CONDITION OF THE DEVICE. IF THE DEVICE BECOMES AVAILABLE, OR ADDITIONAL INFORMATION IS RECEIVED, QUALITY WILL RE-EVALUATE THIS COMPLAINT IN ACCORDANCE TO PROCEDURES. HOWEVER, BECAUSE QUALITY'S EXAMINATION MAY NOT CONCLUSIVELY CONFIRM OR DISPROVE THE REPORT OF PERFORATION, QUALITY ACCEPTS THE PHYSICIAN'S OBSERVATIONS. 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. A REVIEW OF THE COMPLAINT HISTORY DATABASE REVEALED NO SIGNIFICANT TRENDS FOR LOT 6203727. REVIEW OF NONCONFORMING REPORTS REVEALED NO NONCONFORMANCE'S FOR THIS LOT. NO CAPAS ARE ASSOCIATED WITH THIS LOT.

    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. ONCE OUR EVALUATION IS COMPLETE, A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    ACCORDING TO THE AVAILABLE INFORMATION, POSSIBLE PROXIMAL PERFORATION ON PATIENT RIGHT SIDE. SUTURES PLACED IN RTE AND SECURED TO CORPORA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1024149 TITAN SCROTAL ZERO ANG 18CM INFLATABLE PENILE PROSTHESIS FHW COLOPLAST A/S ES89182400 6203727 05708932487344

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Other