BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TITAN OTR NAR SCRO 18CM

    MDR report key: 7631164 · Received June 22, 2018

    Report

    Report Number
    2125050-2018-00461
    Event Type
    Injury
    Date Received
    June 22, 2018
    Date of Event
    May 17, 2018
    Report Date
    July 13, 2018
    Manufacturer
    COLOPLAST A/S
    Product Code
    FHW
    PMA / PMN Number
    P000006
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    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 PROSTHESIS. 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 5851615. 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
    471484 TITAN OTR NAR SCRO 18CM INFLATABLE PENILE PROSTHESIS FHW COLOPLAST A/S QNR9181022 5851615

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Other