BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPECTRA

    MDR report key: 1814157 · Received August 17, 2010

    Report

    Report Number
    2183959-2010-00331
    Event Type
    Malfunction
    Date Received
    August 17, 2010
    Date of Event
    August 10, 2010
    Report Date
    August 10, 2010
    Manufacturer
    AMERICAN MEDICAL SYSTEMS, INC.
    Product Code
    FAE
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    UNABLE TO CONFIRM IF THE EVENT IS RELATED TO A DEVICE MALFUNCTION, DEVICE HAS NOT BEEN REMOVED FROM THE PT. NO CONCLUSION CAN BE DRAWN AT THIS TIME. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE REGARDING A REVISION SURGERY, IT WILL BE RE-EVALUATED AND A F/U REPORT WILL BE SENT.

    Description of Event or Problem · 1

    A (B)(6) MALE WAS IMPLANTED WITH A SPECTRA MALLEABLE DEVICE ON (B)(6) 2010. ON 08/10/2010, DOCTOR REPORTED A COMPLAINT ABOUT THE PERFORMANCE OF THE SPECTRA DEVICE. PT WANTS HIM TO EXPLANT THE SPECTRA DEVICE. ACCORDING TO THE PT, THE SPECTRA DEVICE IS FLEXIBLE AND BENDS DURING INTERCOURSE AND IS LACKING RIGIDITY. DOCTOR PLANS ON REPLACING THIS DEVICE WITH ANOTHER MALLEABLE TYPE. SURGERY HAS NOT BEEN SCHEDULED AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SPECTRA CONCEALABLE PENILE PROSTHESIS FAE AMERICAN MEDICAL SYSTEMS, INC. 720074-01

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Disability