BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AMS AMBICOR PENILE PROSTHESIS

    MDR report key: 11607726 · Received April 2, 2021

    Report

    Report Number
    2124215-2021-07441
    Event Type
    Injury
    Date Received
    April 2, 2021
    Date of Event
    March 8, 2021
    Report Date
    April 2, 2021
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    JCW
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION SUMMARY: BASED ON THE INFORMATION AVAILABLE, THE CAUSE THAT CONTRIBUTED TO THE REPORTED BROKEN CYLINDERS CANNOT BE ESTABLISHED AS THE PRODUCT IS NOT AVAILABLE FOR ANALYSIS. DEVICE HISTORY RECORD (DHR): REVIEW OF MANUFACTURING DOCUMENTATION WAS NOT PERFORMED AS THE SERIAL/LOT NUMBER FOR THIS COMPONENT WAS NOT PROVIDED. DEVICE TECHNICAL ANALYSIS: THE DEVICE IS NOT AVAILABLE FOR ANALYSIS; THEREFORE, NO PHYSICAL OR VISUAL ANALYSIS OF THE PRODUCT COULD BE PERFORMED. THE REPORTED DEVICE PERFORMANCE ALLEGATION CANNOT BE CONFIRMED. LABELING REVIEW: A REVIEW OF THE DEVICE INSTRUCTIONS FOR USE (IFU) WAS COMPLETED AND DID NOT REVEAL ANY EVIDENCE OF DEVICE MISUSE, OFF LABEL USE, OR FAILURE TO FOLLOW INSTRUCTIONS. INVESTIGATION CONCLUSION: BASED ON THE INFORMATION AVAILABLE, A CONCLUSION CODE OF CAUSE NOT ESTABLISHED WAS ASSIGNED TO THIS INVESTIGATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT HAD A REVISION OF AN AMBICOR PENILE PROSTHESIS DUE TO A BROKEN DEVICE, THERE WERE OPEN AREAS IN BOTH CYLINDERS. A NEW AMBICOR PENILE PROSTHESIS WAS IMPLANTED. FOLLOWING THE SURGERY, THE PATIENT WAS STABLE AND IN RECOVERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    507599 AMS AMBICOR PENILE PROSTHESIS DEVICE IMPOTENCE MECHANICAL/HYDRAULIC JCW BOSTON SCIENTIFIC CORPORATION UNK-P-APP

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Hospitalization| R