BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PUMP

    MDR report key: 7826182 · Received August 29, 2018

    Report

    Report Number
    2125050-2018-00626
    Event Type
    Injury
    Date Received
    August 29, 2018
    Date of Event
    August 2, 2018
    Report Date
    August 22, 2018
    Manufacturer
    COLOPLAST A/S
    Product Code
    FHW
    UDI-DI
    05708932319621
    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 CORRECTED IMPLANT DATE AND THE CONCLUSION OF THE INVESTIGATION. ATTEMPTS HAVE BEEN MADE TO OBTAIN ADDITIONAL INFORMATION SURROUNDING THIS EVENT. HOWEVER, ADDITIONAL INFORMATION HAS NOT BEEN RECEIVED. IF ADDITIONAL INFORMATION BECOMES AVAILABLE, THE COMPLAINT WILL BE RE-EVALUATED ACCORDING TO PROCEDURES. 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 6121948. 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
    671035 PUMP INFLATABLE PENILE PROSTHESIS FHW COLOPLAST A/S 5177701400 6121948 05708932319621

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Other