BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AMS AMBICOR

    MDR report key: 77005 · Received February 3, 1997

    Report

    Report Number
    77005
    Event Type
    Injury
    Date Received
    February 3, 1997
    Date of Event
    October 3, 1996
    Report Date
    October 17, 1996
    Manufacturer
    PFIZER HOSP PRODUCTS GRP
    Product Code
    FHW
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE RIGHT CORPOREAL CYLINDER WOULD NOT DEFLATE AND WAS CAUSING PAIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AMS AMBICOR Implant INFLATABLE PENILE PROSTHESIS FHW PFIZER HOSP PRODUCTS GRP * *

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Required Intervention