BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AMS INFLATABLE PENILE PROSTHESIS

    MDR report key: 8549668 · Received April 25, 2019

    Report

    Report Number
    2183959-2019-62559
    Event Type
    Injury
    Date Received
    April 25, 2019
    Date of Event
    March 26, 2019
    Report Date
    June 21, 2019
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    FHW
    UDI-DI
    00878953003948
    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

    THE COMPLAINT COMPONENT WAS RETURNED AND ANALYZED, AND THE REPORTED ALLEGATION WAS NOT CONFIRMED VIA PRODUCT ANALYSIS. THE EVENT CANNOT BE REPRODUCED OR SUBSTANTIATED; THEREFORE, NO ESCALATION TO NCEP, CAPA OR SCAR IS REQUIRED. DEVICE INFORMATION: MODEL NUMBER/CATALOG NUMBER: 72404310, SERIAL NUMBER: (B)(4), BATCH/LOT NUMBER: 944476004, GTIN: (B)(4), MODEL/CATALOG DESCRIPTION: PUMP MS, EXPIRATION DATE 07/13/2020. THE COMPLAINT COMPONENT WAS RETURNED AND ANALYZED, AND THE REPORTED ALLEGATION WAS CONFIRMED VIA PRODUCT ANALYSIS. A LEAK WAS CONFIRMED AT THE CYLINDER TUBING-STRAIN RELIEF JUNCTION DUE TO FATIGUE. THERE WAS ALSO AVULSION ON THE PUMP. THE EVENT CANNOT BE REPRODUCED OR SUBSTANTIATED; THEREFORE, NO ESCALATION TO NCEP, CAPA OR SCAR IS REQUIRED. DEVICE INFORMATION: MODEL NUMBER/CATALOG NUMBER: 72404161, SERIAL NUMBER: (B)(4), BATCH/LOT NUMBER: 942347005, GTIN: (B)(4), MODEL/CATALOG DESCRIPTION: RESERVOIR 65ML PC, EXPIRATION DATE: 07/13/2020. MANUFACTURER DATE: 07/22/2015. THE COMPLAINT COMPONENT WAS RETURNED AND ANALYZED, AND THE REPORTED ALLEGATION WAS NOT CONFIRMED VIA PRODUCT ANALYSIS. THE EVENT CANNOT BE REPRODUCED OR SUBSTANTIATED; THEREFORE, NO ESCALATION TO NCEP, CAPA OR SCAR IS REQUIRED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT HAD THE INFLATABLE PENILE PROSTHESIS REMOVED DUE TO BROKEN TUBING BETWEEN CYLINDER AND RESERVOIR. A NEW INFLATABLE PENILE PROSTHESIS CONSISTING OF 15CM X 12 MM CYLINDERS, PUMP, AND RESERVOIR WERE IMPLANTED AND THE EVENT WAS RESOLVED. FURTHER INFORMATION WAS REQUESTED AND NOT YET RECEIVED. SHOULD ADDITIONAL RELEVANT DETAILS BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    MODEL NUMBER/CATALOG NUMBER 72404310, SERIAL NUMBER (B)(4), BATCH/LOT NUMBER 944476004, GTIN (B)(4), MODEL/CATALOG DESCRIPTION PUMP MS, EXPIRATION DATE 07/13/2020. MANUFACTURER DATE 07/22/2015. MODEL NUMBER/CATALOG NUMBER 72404161, SERIAL NUMBER (B)(4), BATCH/LOT NUMBER 942347005, GTIN (B)(4), MODEL/CATALOG DESCRIPTION RESERVOIR 65ML PC, EXPIRATION DATE 07/13/2020. MANUFACTURER DATE 07/22/2015.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT HAD THE INFLATABLE PENILE PROSTHESIS REMOVED DUE TO BROKEN TUBING BETWEEN CYLINDER AND RESERVOIR. A NEW INFLATABLE PENILE PROSTHESIS CONSISTING OF 15CM X 12 MM CYLINDERS, PUMP, AND RESERVOIR WERE IMPLANTED AND THE EVENT WAS RESOLVED. FURTHER INFORMATION WAS REQUESTED AND NOT YET RECEIVED. SHOULD ADDITIONAL RELEVANT DETAILS BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    343240 AMS INFLATABLE PENILE PROSTHESIS DEVICE IMPOTENCE MECHANICAL/HYDRAULIC FHW BOSTON SCIENTIFIC CORPORATION 72404292 938824003 00878953003948

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Hospitalization| R