BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INFLATABLE PENILE PROSTHESIS

    MDR report key: 2504695 · Received March 22, 2012

    Report

    Report Number
    2183959-2012-00320
    Event Type
    Injury
    Date Received
    March 22, 2012
    Date of Event
    February 22, 2012
    Report Date
    February 22, 2012
    Manufacturer
    AMERICAN MEDICAL SYSTEMS, INC.
    Product Code
    JCW
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). (B)(6).

    Description of Event or Problem · 1

    ON (B)(6) 2012, THE PT UNDERWENT A REPLACEMENT OF HIS INFLATABLE PENILE PROSTHESIS (IPP). ON (B)(6) 2012, THE PT PRESENTED WITH A "SUPERFICIAL PERINEAL WOUND INFECTION WITH SURROUNDING CELLULITIS" THE INFECTION OCCURRED "DUE TO THE PT'S POOR HYGIENE." ON (B)(6) 2012, BLOOD WORK WAS COMPLETED IN THE PHYSICIAN'S OFFICE. ON (B)(6) 2012, THE PT WAS HOSPITALIZED AND TREATED WITH LINEZOLID FOR 4 DAYS AND DISCHARGED ON (B)(6) 2012. ON (B)(6) 2012, THE PT WAS READMITTED TO HOSP. THE PT PRESENTED WITH "ERYTHEMA, SKIN DEHISCENCE, ALLERGIC REACTION TO THE SULFA DRUG." THE PT WAS TREATED WITH BENADRYL FOR THE ALLERGIC REACTION TO MEDS, SWITCHED TO VANCOMYCIN IV FOR 24 HRS." THE PT WAS DISCHARGED FROM HOSP ON (B)(6) 2012.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR Hospitalization| L| O