BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ALPHA I

    MDR report key: 763927 · Received September 22, 2006

    Report

    Report Number
    2125050-2006-00278
    Event Type
    Injury
    Date Received
    September 22, 2006
    Date of Event
    August 10, 2006
    Manufacturer
    COLOPLAST MANUFACTURING US, LLC
    Product Code
    FWH
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    AN EVALUATION IS PENDING THE DECONTAMINATION OF THE COMPONENT(S). AN EVALUATION WILL BE FORWARDED UPON COMPLETION.

    Description of Event or Problem · 1

    ACCORDING TO THE INFORMATION THERE WAS A LEAK IN THE RESERVOIR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ALPHA I INFLATABLE PENILE PROSTHESIS FWH COLOPLAST MANUFACTURING US, LLC 99185 E90293

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Hospitalization| R