BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GYNECARE INTERGEL

    MDR report key: 532231 · Received June 29, 2004

    Report

    Report Number
    2184002-2004-00008
    Event Type
    Injury
    Date Received
    June 29, 2004
    Report Date
    June 29, 2004
    Manufacturer
    LIFECORE BIOMEDICAL, INC.
    Product Code
    MCN
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PT HAD SURGERIES PERFORMED IN 04/02, 11/02, 02/03, 05/03 AND 10/03. IT WAS REPORTED THAT "UNSPECIFIED INJURIES OCCURRED." ADDITIONAL INFO RECEIVED IN 06/04 STATES THAT SHORTLY FOLLOWING PT'S SURGERY, PT DEVELOPED "EXTREME PAIN, SWELLING, AND OTHER SERIOUS INJURIES."

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PT HAD SURGERIES PERFORMED ON 4/12/20002, 11/13/2002, 2/5/2003, 5/13/2003, 5/15/2003 AND 10/13/2003. IT WAS REPORTED THAT "UNSPECIFIED INJURIES OCCURRED." NO OTHER DETAILS OR INFO IS GIVEN. ADDITIONAL INFO (LEGAL COMPLAINT) RECEIVED ON 6/21/2004 STATES THAT SHORTLY FOLLOWING PT'S SURGERY, SHE DEVELOPED "EXTREME PAIN, SWELLING, AND OTHER SERIOUS INJURIES." UPDATE: ADDITIONAL INFO PROVIDED 9/2005 NOTED THAT ACCORDING TO THE PT, THE FOLLOWING IS ALLEGED TO HAVE OCCURRED: GYN. INFECTIONS; INCREASED SEVEVE PELVIC AND ABDOMINAL PAIN; HIGH BLOOD PRESSURE; SEVERE AND INCREASING NAUSEA, VOMITING, AND DRY HEAVES; MALNOURISMENT; EXTREME FATIGUE; BOWEL PROBLEMS (REPEATED COLONOSCOPY AND MEDS FOR IBS); DEBPRESSION; AND INFERTILITY AND EARLY MENOPAUSE. PT STATES GYNECARE INTERGEL WAS INSERTED TWICE.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other