BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AMS INFLATABLE PENILE PROSTHESIS

    MDR report key: 8664797 · Received June 3, 2019

    Report

    Report Number
    2183959-2019-63656
    Event Type
    Injury
    Date Received
    June 3, 2019
    Date of Event
    May 14, 2019
    Report Date
    July 10, 2019
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    FHW
    UDI-DI
    00878953002682
    PMA / PMN Number
    N970012
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    DEVICE ANALYSIS: INFECTION WAS REPORTED. THE AMS700 CYLINDERS WERE VISUALLY INSPECTED AND FUNCTIONALLY TESTED. THERE WAS A LEAK IN ONE CYLINDER DUE TO SHARP INSTRUMENT DAMAGE CONSISTENT WITH EXPLANT DAMAGE. THE OTHER CYLINDER PERFORMED WITHIN SPECIFICATIONS. BASED ON A THOROUGH REVIEW OF THE REPORTED COMPLAINT, THE MOST PROBABLE CAUSE FOR THIS COMPLAINT WAS CONSIDERED UNINTENDED USE ERROR CAUSED OR CONTRIBUTED TO EVENT. THIS COMPLAINT INVESTIGATION CONCLUSION CODE IS UTILIZED FOR THE INTERACTION BETWEEN THE USER AND DEVICE, OR SAMPLE, CAUSED OR CONTRIBUTED TO THE ERROR. THIS INCLUDES UNINTENDED INAPPROPRIATE USE OF THE DEVICE AND INCORRECT SAMPLE PREPARATION. BASED ON THE RESULTS OF THIS INVESTIGATION, NO ESCALATION IS NECESSARY. PUMP ANALYSIS: THE COMPLAINT DEVICE HAS NOT BEEN RETURNED TO DATE FOR ANALYSIS AND THERE ARE NO NCPRS ASSOCIATED WITH THE PRODUCT RETURN FOR THIS SPECIFIC COMPLAINT. THIS INVESTIGATION IS CONSIDERED AS NO PRODUCT RETURN PER WI CIS PRODUCT INVESTIGATION. ADDITIONAL PRODUCT COMPONENT: MODEL NUMBER/CATALOG NUMBER 7241110 SERIAL NUMBER: NULL BATCH/LOT NUMBER 811877003 MODEL/CATALOG DESCRIPTION PUMP CXM

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT EXPERIENCED AN INFECTION AT THE CORPUS SPONGIOSUM PENIS AT THE SITE OF IMPLANT WITH AN INFLATABLE PENILE PROSTHESIS (IPP). THE IPP CYLINDER AND PUMP WERE EXPLANTED AND A NEW IPP CYLINDER AND PUMP WERE IMPLANTED, THE IPP RESERVOIR REMAINS IMPLANTED. THE PHYSICIAN ALLEGES THE INFECTION WAS DUE TO INSUFFICIENT DISINFECTION BY THE PATIENT AFTER IMPLANT AND THE PHYSICIAN APPLIED ANTIBIOTICS AT IMPLANT SITE. SHOULD ADDITIONAL RELEVANT DETAILS BECOME AVAILABLE OR THE PRODUCT WAS RETURNED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED UPON COMPLETION OF PRODUCT ANALYSIS.

    Additional Manufacturer Narrative · 1

    ADDITIONAL PRODUCT COMPONENT: MODEL NUMBER/CATALOG NUMBER: 7241110; SERIAL NUMBER: NULL; BATCH/LOT NUMBER: 811877003; MODEL/CATALOG DESCRIPTION: PUMP CXM.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT EXPERIENCED AN INFECTION AT THE CORPUS SPONGIOSUM PENIS AT THE SITE OF IMPLANT WITH AN INFLATABLE PENILE PROSTHESIS (IPP). THE IPP CYLINDER AND PUMP WERE EXPLANTED AND A NEW IPP CYLINDER AND PUMP WERE IMPLANTED, THE IPP RESERVOIR REMAINS IMPLANTED. THE PHYSICIAN ALLEGES THE INFECTION WAS DUE TO INSUFFICIENT DISINFECTION BY THE PATIENT AFTER IMPLANT AND THE PHYSICIAN APPLIED ANTIBIOTICS AT IMPLANT SITE. SHOULD ADDITIONAL RELEVANT DETAILS BECOME AVAILABLE OR THE PRODUCT WAS RETURNED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED UPON COMPLETION OF PRODUCT ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    455617 AMS INFLATABLE PENILE PROSTHESIS DEVICE IMPOTENCE MECHANICAL/HYDRAULIC FHW BOSTON SCIENTIFIC CORPORATION 72404011 0149176002 00878953002682

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Hospitalization| R