BEUDAMED
    FDA Adverse Event Injury Summary report: N

    I-STOP

    MDR report key: 3653281 · Received January 6, 2014

    Report

    Report Number
    3006302280-2012-00003
    Event Type
    Injury
    Date Received
    January 6, 2014
    Date of Event
    December 15, 2010
    Report Date
    January 14, 2013
    Manufacturer
    CL MEDICAL
    Product Code
    OTN
    Adverse Event
    Yes
    Report Source
    Distributor report
    Reporter Location
    AL, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    PLAINTIFFS' LAWYER REPORTED THAT PT ALLEGEDLY WAS IMPLANTED WITH A CL MEDICAL I-STOP (LOT UNK, REF NO UNK). PT HAD PREVIOUS SURGERY FOR THE SAME PATHOLOGY A YEAR BEFORE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    5241 I-STOP NONE OTN CL MEDICAL UNK UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK WAS IMPLANTED CONCURRENTLY WITH AN UPHOLD YAGINAL| PLAINTIFFS' LAWYER REPORTED IN THE LAWSUIT THAT PT| SUPPORT SYSTEM TO TREAT PELVIC ORGAN PROLAPSE.