BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TITAN SCROTAL ZERO ANG 20CM

    MDR report key: 7698954 · Received July 18, 2018

    Report

    Report Number
    2125050-2018-00527
    Event Type
    Injury
    Date Received
    July 18, 2018
    Date of Event
    June 20, 2018
    Report Date
    August 24, 2018
    Manufacturer
    COLOPLAST A/S
    Product Code
    FHW
    UDI-DI
    05708932487368
    PMA / PMN Number
    P000006
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    REQUESTS FOR THE EXPLANTED PROSTHESIS 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 EXPLANT AND WITHOUT THE REQUESTED INFORMATION, QUALITY CANNOT COMMENT ON THE CONDITION OF THE DEVICE OR THE EVENTS SURROUNDING THIS INCIDENT. IF THE EXPLANTED DEVICE OR ADDITIONAL INFORMATION IS RECEIVED, QUALITY WILL RE-EVALUATE THIS EVENT IN ACCORDANCE WITH PROCEDURES. HOWEVER, BECAUSE QUALITY'S EXAMINATION MAY NOT CONCLUSIVELY CONFIRM OR DISPROVE THE REPORT OF INFECTION, QUALITY ACCEPTS THE PHYSICIAN'S OBSERVATIONS OF SUCH AS THE REASON FOR SURGICAL INTERVENTION. THE REVIEW OF THE DEVICE LOT HISTORY RECORDS BY QUALITY 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. 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 6203661. REVIEW OF NONCONFORMING REPORTS REVEALED NO NONCONFORMANCE'S FOR THIS LOT. NO CAPAS ARE ASSOCIATED WITH THIS LOT. 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, THE DEVICE WAS EXPLANTED DUE TO INFECTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    542343 TITAN SCROTAL ZERO ANG 20CM INFLATABLE PENILE PROSTHESIS FHW COLOPLAST A/S ES89202400 6203661 05708932487368

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Other