BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AMS INFLATABLE PENILE PROSTHESIS

    MDR report key: 8025570 · Received October 31, 2018

    Report

    Report Number
    2183959-2018-60591
    Event Type
    Injury
    Date Received
    October 31, 2018
    Date of Event
    October 2, 2018
    Report Date
    January 24, 2019
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    FHW
    UDI-DI
    00878953002699
    PMA / PMN Number
    N970012
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    MODEL NUMBER/CATALOG NUMBER 72404161; SERIAL NUMBER (B)(4); BATCH/LOT NUMBER 942348010; MODEL/CATALOG DESCRIPTION RESERVOIR 65ML PC. MODEL NUMBER/CATALOG NUMBER 72404310; SERIAL NUMBER (B)(4); BATCH/LOT NUMBER 100255001; MODEL/CATALOG DESCRIPTION PUMP MS.

    Additional Manufacturer Narrative · 0

    MODEL NUMBER/CATALOG NUMBER 72404161, SERIAL NUMBER (B)(4), BATCH/LOT NUMBER 942348010, MODEL/CATALOG DESCRIPTION RESERVOIR 65ML PC. MODEL NUMBER/CATALOG NUMBER 72404310, SERIAL NUMBER (B)(4), BATCH/LOT NUMBER 100255001, MODEL/CATALOG DESCRIPTION PUMP MS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT HAD THE CYLINDER REPLACED DUE TO THE CURVED PENIS AND COMPLAINED OF PAIN. THE CURVED PENIS WAS DUE TO A PATIENT MEDICAL PROBLEM. THE PATIENT OUTCOME WAS REPORTED AS THE PATIENT "GOT WELL." DEVICE EVALUATION: THE COMPLAINT COMPONENT WAS RETURNED AND ANALYZED, AND THE REPORTED ALLEGATION OF PAIN WAS NOT CONFIRMED VIA PRODUCT ANALYSIS. THE REPORTED ALLEGATIONS COULD NOT BE CONFIRMED. THE EVENT CANNOT BE REPRODUCED OR SUBSTANTIATED; THEREFORE, NO ESCALATION TO NCEP, CAPA OR SCAR IS REQUIRED. FURTHER INFORMATION WAS REQUESTED AND NOT YET RECEIVED. SHOULD ADDITIONAL RELEVANT DETAILS BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT HAD THE CYLINDER REPLACED DUE TO THE CURVED PENIS AND COMPLAINED OF PAIN. THE CURVED PENIS WAS DUE TO A PATIENT MEDICAL PROBLEM. THE PATIENT OUTCOME WAS REPORTED AS THE PATIENT "GOT WELL."

    Additional Manufacturer Narrative · 1

    MODEL NUMBER/CATALOG NUMBER 72404161, SERIAL NUMBER (B)(4), BATCH/LOT NUMBER 942348010, MODEL/CATALOG DESCRIPTION RESERVOIR 65ML PC. MODEL NUMBER/CATALOG NUMBER 72404310, SERIAL NUMBER (B)(4), BATCH/LOT NUMBER 100255001, MODEL/CATALOG DESCRIPTION PUMP MS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT HAD THE CYLINDER REPLACED DUE TO THE CURVED PENIS AND COMPLAINED OF PAIN. THE CURVED PENIS WAS DUE TO A PATIENT MEDICAL PROBLEM. THE PATIENT OUTCOME WAS REPORTED AS THE PATIENT "GOT WELL."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    864563 AMS INFLATABLE PENILE PROSTHESIS DEVICE IMPOTENCE MECHANICAL/HYDRAULIC FHW BOSTON SCIENTIFIC CORPORATION 72404012 926946003 00878953002699

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Hospitalization| R