BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AMS INFLATABLE PENILE PROSTHESIS WITH INHIBIZONE

    MDR report key: 8140208 · Received December 6, 2018

    Report

    Report Number
    2183959-2018-61436
    Event Type
    Injury
    Date Received
    December 6, 2018
    Date of Event
    November 29, 2019
    Report Date
    June 5, 2019
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    FHW
    UDI-DI
    00878953009797
    PMA / PMN Number
    N970012
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UT, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    SUSPECT MEDICAL DEVICE, DEVICE MANUFACTURE DATE: RESERVOIR GTIN #: (B)(4); UPN#: 720185-01; BATCH/LOT #: 1000119971; MFG DATE: 06/15/2018; EXP DATE: 06/14/2020. DEVICE NOT RETURNED FOR EVALUATION.

    Additional Manufacturer Narrative · 0

    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. SUSPECT MEDICAL DEVICE, DEVICE MANUFACTURE DATE: RESERVOIR: GTIN #: (B)(4), UPN#: 720185-01, BATCH/LOT#: 1000119971, MFG DATE: 06/15/2018, EXP DATE: 06/14/2020.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT'S AMS700 INFLATABLE PENILE PROSTHESIS CYLINDERS AND PUMP WERE REMOVED BECAUSE THE PROXIMAL CYLINDERS WERE BULGING (HERNIATION) DUE TO OVERSIZED CYLINDERS AND POOR TISSUE QUALITY. DOWNSIZED AMS700 18CM CYLINDERS REPLACED THE 21CM CYLINDERS WITH GOOD PATIENT OUTCOME.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT'S AMS700 INFLATABLE PENILE PROSTHESIS CYLINDERS AND PUMP WERE REMOVED BECAUSE THE PROXIMAL CYLINDERS WERE BULGING (HERNIATION) DUE TO OVERSIZED CYLINDERS AND POOR TISSUE QUALITY. DOWNSIZED AMS700 18CM CYLINDERS REPLACED THE 21CM CYLINDERS WITH GOOD PATIENT OUTCOME.

    Additional Manufacturer Narrative · 1

    SUSPECT MEDICAL DEVICE, DEVICE MANUFACTURE DATE: RESERVOIR, GTIN # (B)(4), UPN# 720185-01, BATCH/LOT # 1000119971, MFG DATE 06/15/2018, EXP DATE 06/14/2020.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT'S AMS700 INFLATABLE PENILE PROSTHESIS CYLINDERS AND PUMP WERE REMOVED BECAUSE THE PROXIMAL CYLINDERS WERE BULGING DUE TO OVERSIZED PROXIMAL CYLINDERS AND POOR TISSUE QUALITY. AMS700 18CM CYLINDERS REPLACED THE 21CM CYLINDERS WITH GOOD PATIENT OUTCOME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    978463 AMS INFLATABLE PENILE PROSTHESIS WITH INHIBIZONE DEVICE IMPOTENCE MECHANICAL/HYDRAULIC FHW BOSTON SCIENTIFIC CORPORATION 72404233-12 1000107093 00878953009797

    Patients

    Seq Age Sex Outcome Treatment
    1 42 YR Hospitalization| R