BEUDAMED
    FDA Adverse Event Injury Summary report: N

    (2BO)ALPHA I 20CM SCROTAL

    MDR report key: 7716322 · Received July 24, 2018

    Report

    Report Number
    2125050-2018-00551
    Event Type
    Injury
    Date Received
    July 24, 2018
    Date of Event
    June 26, 2018
    Report Date
    August 24, 2018
    Manufacturer
    COLOPLAST A/S
    Product Code
    FHW
    PMA / PMN Number
    P000006
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    QUALITY WAS UNSUCCESSFUL IN SECURING THE EXPLANTED PROSTHESIS FOR EVALUATION. WITHOUT THE BENEFIT OF ANALYZING THE EXPLANT, QUALITY CANNOT CONFIRM ANY OBSERVATIONS AND CANNOT COMMENT ON THE CONDITION OF THE PROSTHESIS. IF THE EXPLANTED DEVICE BECOMES AVAILABLE, OR ADDITIONAL INFORMATION IS RECEIVED, QUALITY WILL RE-EVALUATE THIS COMPLAINT IN ACCORDANCE TO PROCEDURES. 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 0914753. 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 WITHOUT THE BENEFIT OF EXAMINATION AND TESTING, COLOPLAST IS PRECLUDED FROM COMMENTING ON THE CONDITION OF THE DEVICE OR THE CAUSE OF THE OCCURRENCE.

    Description of Event or Problem · 1

    ACCORDING TO THE AVAILABLE INFORMATION, THERE WAS A VISIBLE CRACK IN PUMP TUBING. RESERVOIR DRAINED, PLUGGED AND RETAINED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    556411 (2BO)ALPHA I 20CM SCROTAL INFLATABLE PENILE PROSTHESIS FHW COLOPLAST A/S 5187501000 0914753

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR Other