BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PUMP

    MDR report key: 7781193 · Received August 14, 2018

    Report

    Report Number
    2125050-2018-00598
    Event Type
    Injury
    Date Received
    August 14, 2018
    Date of Event
    June 28, 2018
    Report Date
    August 24, 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 CONCLUSION OF THE INVESTIGATION. 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 6203696. THE MOST LIKELY ROOT CAUSE OF THE EVENT CANNOT BE DETERMINED AT THIS TIME. IF THE DEVICE OR ADDITIONAL INFORMATION IS RECEIVED, QUALITY WILL RE-EVALUATE THIS EVENT IN ACCORDANCE WITH PROCEDURES. 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, WOUND DEHISCENCE, EXPOSED IMPLANT. NON-MALFUNCTION EXPLANT

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    621195 PUMP INFLATABLE PENILE PROSTHESIS FHW COLOPLAST A/S 5177701400 6203696 05708932319621

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Other