BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    2124215-2021-08177

    MDR report key: 11649380 · Received April 12, 2021

    Report

    Report Number
    2124215-2021-08177
    Event Type
    Malfunction
    Date Received
    April 12, 2021
    Date of Event
    March 22, 2021
    Report Date
    April 12, 2021
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    JCW
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT WITH AN UNSPECIFIED PENILE PROSTHESIS WAS EXPERIENCING MECHANICAL ISSUES. NO ADDITIONAL INFORMATION WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    551380 JCW BOSTON SCIENTIFIC CORPORATION UNK-D-PELVIC HEALTH - MEN

    Patients

    Seq Age Sex Outcome Treatment
    1