BEUDAMED
    FDA Adverse Event Other Summary report: N

    SPECTRA CONCEALABLE PENILE PROSTHESIS

    MDR report key: 2043716 · Received March 28, 2011

    Report

    Report Number
    2183959-2011-00116
    Event Type
    Other
    Date Received
    March 28, 2011
    Date of Event
    February 25, 2011
    Report Date
    February 25, 2011
    Manufacturer
    AMERICAN MEDICAL SYSTEMS, INC.
    Product Code
    FAE
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICES RETURNED TO AMS LOT/SERIAL NUMBERS: (B)(4). IMPLANTED DEVICES LOT/SERIAL NUMBERS: (B)(4). PACKAGE WAS RATED UNDETERMINABLE, INVESTIGATION IS ONGOING.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A PROCEDURE ON (B)(6) 2011 THE DEVICE WAS OPENED BUT WAS NOT USED DUE TO FOREIGN MATERIAL DESCRIBED AS "BLUE FUZZ" SURROUNDING THE PACKAGING. THE OPENED DEVICE WAS REC'D BY AMS ON (B)(6) 2011. THE DEVICE (LOT/SERIAL # (B)(4)) CONTAINED BOTH THE CYLINDERS. THERE WAS BLUE FOREIGN MATERIAL NOTED IN BOTH THE EXTERIOR AND INTERIOR SURFACES OF THE PACKAGE AND ON THE CYLINDERS. THERE WAS LOOSE BLUE FOREIGN MATERIAL ON THE EXTERIOR AND INTERIOR SURFACES OF THE TRAYS, ON THE PAPER COVER THE EXTERIOR OF THE BOX. MOST OF THE BLUE MATERIAL WAS LESS THEN 1 MM IN SIZE WITH A FEW MEASURING APPROX 2 MM LONG. LOT HISTORY WAS CHECKED WHICH INDICATED THAT THERE WERE 4 ADD'L DEVICES IN THE LOT, 2 WERE IMPLANTED (LOT/SERIAL# (B)(4)) AND 2 WERE IN THE AMS'S WAREHOUSE (LOT/SERIAL # (B)(4)). THE TWO DEVICES WERE REC'D FROM THE WAREHOUSE UNOPENED THE ANALYSIS REVEALED BOTH DEVICES HAVE SIMILAR BLUE FOREIGN MATERIAL ON THE EXTERIOR SURFACES OF THE DEVICE TRAYS AND PAPER COVERS. NO FOREIGN MATERIAL WAS IDENTIFIED IN THE INTERIOR PACKAGING; ALL OF THE FOREIGN MATERIAL WAS ISOLATED TO THE EXTERIOR OF THE PACKAGING. THE 2 DEVICES THAT WERE NOT IMPLANTED (LOT/SERIAL# (B)(4)) WERE ANALYZED. CURRENTLY THERE ARE NO COMPLAINTS REPORTED TO AMS. THROUGH ADD'L INVESTIGATION AMS HAS CONCLUDED THE BLUE FOREIGN MATERIAL FOUND IN THE OPENED PACKAGE (LOT/SERIAL# (B)(4)) APPEARS TO HAVE BEEN TRANSFERRED INTO THE INTERIOR OF THE PACKAGING. THE BLUE FOREIGN MATERIAL IS UNK TO AMS AND HAS BEEN SENT TO AN INDEPENDENT EXTERNAL LAB FOR ANALYSIS. THIS COMPLAINT WILL BE UPDATED AS ADD'L INFO BECOMES AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SPECTRA CONCEALABLE PENILE PROSTHESIS PENILE PROSTHESIS FAE AMERICAN MEDICAL SYSTEMS, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 45 YR