BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TITAN ZERO ANG CYLINDER 26CM

    MDR report key: 7589258 · Received June 11, 2018

    Report

    Report Number
    2125050-2018-00443
    Event Type
    Injury
    Date Received
    June 11, 2018
    Date of Event
    May 10, 2018
    Report Date
    July 25, 2018
    Manufacturer
    COLOPLAST A/S
    Product Code
    FHW
    UDI-DI
    05708932487443
    PMA / PMN Number
    P000006
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    REQUESTS FOR THE DEVICE AND FOR ADDITIONAL INFORMATION SURROUNDING THIS EVENT HAVE BEEN MADE. HOWEVER, TO DATE NEITHER THE DEVICE NOR THE INFORMATION HAS BEEN RECEIVED. WITHOUT THE BENEFIT OF ANALYZING THE DEVICE AND WITHOUT THE REQUESTED INFORMATION, QUALITY CANNOT COMMENT ON THE CONDITION OF THE DEVICE OR THE EVENTS SURROUNDING THIS INCIDENT. 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 5813222. THE REVIEW OF THE DEVICE LOT HISTORY RECORDS BY QUALITY ASSURANCE INDICATES THIS LOT PASSED STERILITY TESTING PRIOR TO BEING RELEASED. BASED ON THIS KNOWLEDGE, QUALITY CONCLUDES THAT THE DEVICE WAS STERILE PRIOR TO THE DEVICE PACKAGING BEING OPENED AND THAT THE INFECTION ORIGINATED FROM SOURCE(S) OTHER THAN THE DEVICE. MANAGEMENT ROUTINELY REVIEWS EVENTS SUCH AS THIS AND MONITORS COMPLAINT LEVELS. ADDITIONALLY, EVENTS OF THIS TYPE ARE CAPTURED IN THE PRODUCT RISK DOCUMENTATION. BASED ON THIS INFORMATION, NO FURTHER CORRECTIVE ACTION IS REQUIRED AT THIS TIME.

    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, INFECTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    429246 TITAN ZERO ANG CYLINDER 26CM INFLATABLE PENILE PROSTHESIS FHW COLOPLAST A/S E179262400 5813222 05708932487443

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR Other