BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AMS SPECTRA CONCEALABLE PENILE PROSTHESIS

    MDR report key: 3110987 · Received May 9, 2013

    Report

    Report Number
    2183959-2013-00827
    Event Type
    Injury
    Date Received
    May 9, 2013
    Date of Event
    March 31, 2013
    Report Date
    April 23, 2013
    Manufacturer
    AMERICAN MEDICAL SYSTEMS, INC.
    Product Code
    FHW
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VT, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    REAR TIP EXTENDER: CATALOG # 72404324, SERIAL # (B)(4), MANUFACTURE DATE: 03/2013; EXPIRATION DATE: 03/08/2013. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE REGARDING THIS EVENT, IT WILL BE RE-EVALUATED AND A FOLLOW-UP REPORT WILL BE SENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PT PRESENTED TO THE EMERGENCY ROOM WITH COMPLAINTS OF: NO BOWEL MOVEMENT SINCE HIS PENILE PROSTHESIS IMPLANT SURGERY DATE, PAIN AND FEVER. THE ON-CALL SURGEON WAS CALLED IN, THE PT WAS TAKEN TO THE OPERATING ROOM AND THE DEVICE WAS REMOVED. POST-SURGERY, THE PT WAS SENT TO RADIOLOGY. IMAGING REVEALED THE DEVICE REAR TIP EXTENDERS IN THE PT'S RECTUM AND WERE SUCCESSFULLY REMOVED. UPON DISCHARGE FROM THE HOSPITAL, NO PT COMPLICATIONS WERE NOTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    204686 AMS SPECTRA CONCEALABLE PENILE PROSTHESIS PENILE PROSTHESIS FHW AMERICAN MEDICAL SYSTEMS, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Hospitalization| R