BEUDAMED
    FDA Adverse Event Injury Summary report: N

    I-STOP

    MDR report key: 4366447 · Received December 19, 2014

    Report

    Report Number
    3006302280-2014-00008
    Event Type
    Injury
    Date Received
    December 19, 2014
    Date of Event
    May 5, 2009
    Report Date
    December 17, 2014
    Manufacturer
    CL MEDICAL
    Product Code
    OTN
    Adverse Event
    Yes
    Report Source
    Distributor report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    PLAINTIFF'S LAWYER REPORTED THAT PATIENT ALLEGEDLY WAS IMPLANTED WITH A CL MEDICAL I-STOP (LOT INCORRECT, REF. UNK). PATIENT COMPLAINED ABOUT EROSION, INFECTION, PAIN, URINARY TRACT INFECTIONS AND CONTINUED INCONTINENCE FOLLOWING REVISION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    836662 I-STOP NONE OTN CL MEDICAL UNK UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK