BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AMS 700 INFLATABLE PENILE PROSTHESIS

    MDR report key: 1883355 · Received August 11, 2010

    Report

    Report Number
    2183959-2010-00329
    Event Type
    Injury
    Date Received
    August 11, 2010
    Date of Event
    July 9, 2010
    Report Date
    August 17, 2010
    Manufacturer
    AMERICAN MEDICAL SYSTEMS, INC.
    Product Code
    JCW
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CATALOG NUMBERS 72400151, 72400152. (B)(4). UNABLE TO CONFIRM IF THE EVENT IS RELATED TO A DEVICE MALFUNCTION, DEVICE HAS NOT BEEN RETURNED FOR ANALYSIS AND REASON PROMPTING THIS EVENT WAS NOT PROVIDED. NO CONCLUSION CAN BE DRAWN AT THIS TIME. THREE ATTEMPTS HAVE BEEN MADE TO OBTAIN ADDITIONAL INFO AND WERE UNSUCCESSFUL. SHOULD ADDITIONAL INFO BECOMES AVAILABLE REGARDING A REVISION SURGERY IT WILL BE RE-EVALUATED AND A F/U REPORT SENT.

    Description of Event or Problem · 1

    A (B)(6) OLD, MALE, WAS IMPLANTED WITH AN IPP DEVICE ON (B)(6) 2006. ON (B)(6) 2009, THE ENTIRE DEVICE WAS REMOVED AND REPLACED. REASON NOT INDICATED. AMS HAS REQUESTED ADDITIONAL INFO.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AMS 700 INFLATABLE PENILE PROSTHESIS IPP JCW AMERICAN MEDICAL SYSTEMS, INC. 363912003

    Patients

    Seq Age Sex Outcome Treatment
    1 41 YR Hospitalization| R