BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AMS INFLATABLE PENILE PROSTHESIS

    MDR report key: 8026055 · Received October 31, 2018

    Report

    Report Number
    2183959-2018-60609
    Event Type
    Injury
    Date Received
    October 31, 2018
    Date of Event
    January 1, 2018
    Report Date
    January 29, 2019
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    FHW
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 0

    IT WAS REPORTED THAT AN 18CM LGX INFLATABLE PENILE PROSTHESIS (IPP) WAS EXPLANTED DUE TO UNSPECIFIED REASONS. IT IS UNCLEAR IF A 21CM X 12MM OR AN 18CM X 12MM LGX IPP WAS IMPLANTED. FURTHER INFORMATION WAS REQUESTED AND NOT YET RECEIVED. SHOULD ADDITIONAL RELEVANT DETAILS BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. IT WAS FURTHER REPORTED THAT THE PHYSICIAN INITIALLY ATTEMPTED TO IMPLANT THE 21CM X 12MM IPP. HOWEVER, THE SIZING WAS INCORRECT FOR THE PATIENT. A 18CM X 12MM LGX IPP WAS IMPLANTED. DEVICE EVALUATION: THE COMPLAINT COMPONENT WAS NOT RETURNED FOR ANALYSIS, AND THE PRODUCT RECORD REVIEW REVEALED NO ADDITIONAL INFORMATION RELATED TO THE COMPLAINT. NO ALLEGATION(S) WERE REPORTED. THE EVENT CANNOT BE REPRODUCED OR SUBSTANTIATED; THEREFORE, NO ESCALATION TO NCEP, CAPA, OR SCAR IS REQUIRED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AN 18CM LGX INFLATABLE PENILE PROSTHESIS (IPP) WAS EXPLANTED DUE TO UNSPECIFIED REASONS. IT IS UNCLEAR IF A 21CM X 12MM OR AN 18CM X 12MM LGX IPP WAS IMPLANTED. 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 · 1

    IT WAS REPORTED THAT AN 18CM LGX INFLATABLE PENILE PROSTHESIS (IPP) WAS EXPLANTED DUE TO UNSPECIFIED REASONS. IT IS UNCLEAR IF A 21CM X 12MM OR AN 18CM X 12MM LGX IPP WAS IMPLANTED. FURTHER INFORMATION WAS REQUESTED AND NOT YET RECEIVED. SHOULD ADDITIONAL RELEVANT DETAILS BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. IT WAS FURTHER REPORTED THAT THE PHYSICIAN INITIALLY ATTEMPTED TO IMPLANT THE 21CM X 12MM IPP. HOWEVER, THE SIZING WAS INCORRECT FOR THE PATIENT. A 18CM X 12MM LGX IPP WAS IMPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    863363 AMS INFLATABLE PENILE PROSTHESIS DEVICE IMPOTENCE MECHANICAL/HYDRAULIC FHW BOSTON SCIENTIFIC CORPORATION UNK-P-IPP

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Hospitalization| R