BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AMS INFLATABLE PENILE PROSTHESIS

    MDR report key: 10574622 · Received September 23, 2020

    Report

    Report Number
    2183959-2020-04273
    Event Type
    Injury
    Date Received
    September 23, 2020
    Date of Event
    August 28, 2020
    Report Date
    November 17, 2020
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    FHW
    UDI-DI
    00878953003986
    PMA / PMN Number
    N970012
    Removal / Correction Number
    RES #85562
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SF
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    CHANGE TO REMEDIAL ACT UNIT AND CORRECTION/REMOVAL REPORTING # TO INCLUDE RECALL INFORMATION. UPON RECEIPT AT OUR POST MARKET QUALITY ASSURANCE LABORATORY, THE AMS 700 MOMENTARY SQUEEZE (MS) PUMP WAS VISUALLY INSPECTED, AND NO LEAKS WERE FOUND. THE PUMP WAS FUNCTIONALLY TESTED AND DID NOT PASS THE ACTIVATION TEST. THE DEVICE HISTORY RECORD (DHR) CONFIRMED THAT THE DEVICES MET ALL MATERIAL, ASSEMBLY AND PERFORMANCE SPECIFICATIONS. PRODUCT ANALYSIS WAS UNABLE TO CONFIRM THE REPORTED ALLEGATIONS RELATED TO "EROSION" AND "PAIN"; HOWEVER, PRODUCT ANALYSIS IDENTIFIED PUMP MALFUNCTION.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DUE TO EROSION AND SCROTAL PAIN THE PATIENT HAD HIS INFLATABLE PENILE PROSTHESIS (IPP) EXPLANTED. IT WAS EXPLAINED THAT THE DEVICE TUBING HAD ERODED THROUGH HIS SCROTUM, AND ACCORDING TO THE PHYSICIAN THE CYLINDER WOULD SOON ERODE AS WELL AND PUNCTURE THROUGH THE CORPORAL TISSUE AND SKIN. THE PHYSICIAN WILL REIMPLANT THE DEVICE AFTER THE PATIENT HAS HEALED. THE PATIENT WAS STABLE FOLLOWING THIS SURGERY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DUE TO EROSION AND SCROTAL PAIN THE PATIENT HAD HIS INFLATABLE PENILE PROSTHESIS (IPP) EXPLANTED. IT WAS EXPLAINED THAT THE DEVICE TUBING HAD ERODED THROUGH HIS SCROTUM, AND ACCORDING TO THE PHYSICIAN THE CYLINDER WOULD SOON ERODE AS WELL AND PUNCTURE THROUGH THE CORPORAL TISSUE AND SKIN. THE PHYSICIAN WILL REIMPLANT THE DEVICE AFTER THE PATIENT HAS HEALED. THE PATIENT WAS STABLE FOLLOWING THIS SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1039753 AMS INFLATABLE PENILE PROSTHESIS DEVICE IMPOTENCE MECHANICAL/HYDRAULIC FHW BOSTON SCIENTIFIC CORPORATION 72404310 1000105274 00878953003986

    Patients

    Seq Age Sex Outcome Treatment
    1 44 YR Hospitalization| R PUMP LOT NUMBER- 1000105274| PUMP LOT NUMBER- 1000105274| RESERVOIR LOT NUMBER- 1000115309| RESERVOIR LOT NUMBER- 1000115309| PUMP LOT NUMBER- 1000105274| RESERVOIR LOT NUMBER- 1000115309