BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AMS INFLATABLE PENILE PROSTHESIS WITH INHIBIZONE

    MDR report key: 9377983 · Received November 26, 2019

    Report

    Report Number
    2183959-2019-67691
    Event Type
    Injury
    Date Received
    November 26, 2019
    Date of Event
    November 4, 2019
    Report Date
    December 4, 2019
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    FHW
    UDI-DI
    00878953003603
    PMA / PMN Number
    N970012
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION RECEIVED THAT THE PATIENT OUTCOME WAS REPORTED TO BE FINE. SYSTEM COMPONENTS RESERVOIR MODEL- 72404155 LOT SN- (B)(4) MFG DATE- 10/08/2012 EXP DATE- 09/24/2014 GTIN- (B)(4).

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT EXPERIENCED A REPLACEMENT OF AN INFLATABLE PENILE PROSTHESIS(IPP) DEVICE DUE TO THE RESERVOIR TUBING BEING BROKEN AND THE PROSTHESIS NOT FUNCTIONING. A PATIENT OUTCOME WAS NOT REPORTED.

    Additional Manufacturer Narrative · 1

    SYSTEM COMPONENTS: RESERVOIR: MODEL- 72404155, LOT SN- (B)(4), MFG DATE- 10/08/2012, EXP DATE- 09/24/2014, GTIN- (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT EXPERIENCED A REPLACEMENT OF AN INFLATABLE PENILE PROSTHESIS (IPP) DEVICE DUE TO THE RESERVOIR TUBING BEING BROKEN AND THE PROSTHESIS NOT FUNCTIONING. A PATIENT OUTCOME WAS NOT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1172241 AMS INFLATABLE PENILE PROSTHESIS WITH INHIBIZONE DEVICE IMPOTENCE MECHANICAL/HYDRAULIC FHW BOSTON SCIENTIFIC CORPORATION 72404252 72404155 00878953003603

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Hospitalization| O