BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GYNECARE INTERGEL

    MDR report key: 2092873 · Received May 11, 2011

    Report

    Report Number
    2184002-2011-00001
    Event Type
    Injury
    Date Received
    May 11, 2011
    Report Date
    May 9, 2011
    Manufacturer
    LIFECORE BIOMEDICAL, LLC
    Product Code
    MCN
    PMA / PMN Number
    P990015
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    THE DISTRIBUTOR OF INTERGEL RECEIVED AN E-MAIL FROM THE PATIENT STATING THE FOLLOWING: I HAVE BEEN SUFFERING FROM DIFFERENT SYMPTOMS, WHICH I AM ADVISED ARE NOT ATTRIBUTABLE TO THE ORIGINAL PATHOLOGY. THE SURGEON WHO ADVISED ME THAT INTERGEL WAS USED IN MY CASE BELIEVES THAT THIS SHOULD BE LOOKED IN TO AS IT MAY WELL EXPLAIN MY SYMPTOMS. AS OF THE TIME OF THIS REPORT, ADDITIONAL INFORMATION HAS BEEN REQUESTED FROM THE PATIENT, BUT NOT RECEIVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GYNECARE INTERGEL ABSORBABLE ADHESION BARRIER MCN LIFECORE BIOMEDICAL, LLC GYNECARE INTERGEL UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Other INFORMATION NOT AVAILABLE.