BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AMS INFLATABLE PENILE PROSTHESIS

    MDR report key: 9189007 · Received October 14, 2019

    Report

    Report Number
    2183959-2019-66832
    Event Type
    Injury
    Date Received
    October 14, 2019
    Date of Event
    January 1, 2007
    Report Date
    October 14, 2019
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    FHW
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    AS THE COMPLAINT COMPONENT WAS NOT RETURNED FOR ANALYSIS, AND THE PRODUCT RECORD REVIEW REVEALED NO ADDITIONAL INFORMATION RELATED TO THE COMPLAINT. THE REPORTED ALLEGATIONS COULD NOT BE CONFIRMED. 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 THE JOURNAL OF SEXUAL MEDICINE PUBLISHED A RETROSPECTIVE EVALUATION ON THE RELATIONSHIP BETWEEN THE URINE CULTURE RESULT BEFORE PROCEDURE AND INFECTIOUS BACTERIA OF ARTIFICIAL URINARY DEVICES TARGETING 454 DEVICES IN 422 MALE PATIENTS PLACED WITH ARTIFICIAL URETHRAL SPHINCTER (AUS) AND/OR PENILE PROSTHESIS (PP) BETWEEN 2007 TO 2015. AS A RESULT, 15 DEVICES (3%) HAD INFECTION OCCURRED UPON THE MEDIAN FOLLOW-UP OF 15 MONTHS. BASED ON THE URINE CULTURE RESULT BEFORE THE PROCEDURE, THE PLACED DEVICES WERE CLASSIFIED INTO STERILE GROUP AND POSITIVE GROUP, BUT THERE WAS NO SIGNIFICANT INTERGROUP DIFFERENCE IN THE INFECTION RATE BETWEEN THE STERILE GROUP AND POSITIVE GROUP (3.3% VS 4.3%, P=0.70). ONLY 1 DEVICE OUT OF THE 15 DEVICES IN WHICH THE DEVICE INFECTIOUS BACTERIA AND URINE CULTURE RESULT BEFORE PROCEDURE WERE MATCHED. IN THE MULTIVARIATE ANALYSIS, AUS PLACEMENT GROUP HAD 4.5-FOLD HIGHER RISK OF POSITIVE URINE CULTURE RESULT COMPARED TO PP PLACEMENT GROUP (45% VS 18%, P <0.001), BUT INFECTION RATE WAS SIMILAR (3% VS 3%, P=0.89). THUS, URINE CULTURE RESULT BEFORE THE PROCEDURE WAS NOT RELATED TO THE INFECTIOUS BACTERIA ON ARTIFICIAL URINARY TRACT DEVICES. PREOPERATIVE URINE CULTURE RESULTS CORRELATE POORLY WITH BACTERIOLOGY OF UROLOGIC PROSTHETIC DEVICE INFECTIONS. [J SEX MED 2017; 14:163-168]. DOI: 10.1016/J.JSXM.2016.10.017. PMID: 28065350. THIS REPORT IS FOR THE 7 IPP DEVICES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    979496 AMS INFLATABLE PENILE PROSTHESIS DEVICE IMPOTENCE MECHANICAL/HYDRAULIC FHW BOSTON SCIENTIFIC CORPORATION UNK-P-IPP

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R