BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AMS INFLATABLE PENILE PROSTHESIS

    MDR report key: 8685330 · Received June 10, 2019

    Report

    Report Number
    2183959-2019-63901
    Event Type
    Injury
    Date Received
    June 10, 2019
    Date of Event
    April 3, 2019
    Report Date
    June 10, 2019
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    FHW
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPLAINT COMPONENT WAS RETURNED AND ANALYZED, AND THE REPORTED ALLEGATION WAS CONFIRMED VIA PRODUCT ANALYSIS. THE EVENT CANNOT BE REPRODUCED OR SUBSTANTIATED; THEREFORE, NO ESCALATION TO NCEP, CAPA OR SCAR IS REQUIRED. DEVICE NOT RETURNED FOR EVALUATION.

    Description of Event or Problem · 1

    NCPR CREATED FOR RETURN OF IPP TO (B)(4) FOR UNSPECIFIED REASONS. ADDITIONAL INFORMATION FROM THE PRODUCT EXPERIENCE FORM RECEIVED WITH THE RETURNED PRODUCT STATED THAT THE DEVICE HAD STOPPED WORKING SOMETIME IN 2015, THE EXACT DATE WAS UNKNOWN. THE PATIENT HAS REPORTED PAIN, THAT THE DEVICE WAS BOTHERING HIM AND HE WANTED IT REMOVED. THE DEVICE WAS NO LONGER BEING USED. THE DEVICE WAS EXPLANTED. NO OTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    477900 AMS INFLATABLE PENILE PROSTHESIS DEVICE IMPOTENCE MECHANICAL/HYDRAULIC FHW BOSTON SCIENTIFIC CORPORATION UNK-P-IPP

    Patients

    Seq Age Sex Outcome Treatment
    1 89 YR Hospitalization| R