BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTERGEL

    MDR report key: 1103523 · Received August 7, 2008

    Report

    Report Number
    MW5007938
    Event Type
    Injury
    Date Received
    August 7, 2008
    Date of Event
    June 27, 2002
    Report Date
    August 7, 2008
    Manufacturer
    GYNECARE
    Product Code
    MCN
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CA, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    DEVELOPED INFECTION 2 DAYS AFTER BEING RELEASED FROM HOSPITAL AFTER HAVING ABDOMINAL SURGERY. LAPAROSCOPIC SURGERY FOR LEFT URETEROLYSIS FOR RETROPERITONEAL ADHESIONS AND PELVIC PERITONEAL ENDOMETRIOSIS, LEFT SALPINGP-OOPHORECTOMY FOR SEVERE PELVIC PERITONEAL ADHESIONS AND ENDOMETRIOSIS, AND APPENDECTOMY. GYNECARE INTERGEL WAS USED TO COVER THE ENTIRE RAW PELVIC PERITONEAL AREA. I DEVELOPED SEVERE PAIN IMMEDIATELY UPON BEING RELEASED FROM THE HOSPITAL AND THEN ADMITTED BACK TO THE E.R. AND KEPT FOR OBSERVATION OVERNIGHT. A FEW DAYS LATER, I RETURNED HOME TO BE SEEN BY MY FAMILY DOCTOR AND WAS TREATED FOR A SEVERE INFECTION. THE INFECTION DID NOT GO AWAY, BUT HAVE BEEN EXPERIENCING PAIN WHICH HAS PERSISTED OVER THE YEARS, TO WHICH IS NOW CHARACTERIZED AS CHRONIC. SOME TIMES DEBILITATING PAIN. I CURRENTLY AM SCHEDULED TO SEE A SURGICAL SPECIALIST FOR POSSIBLE SURGERY FOR SYMPTOMATIC REOCCURRENCE OF ADHESIONS AND COMPLETE DIAGNOSIS OF CHRONIC., DEBILITATING -AT TIMES- PAIN. SYMPTOMS ARE WORSE NOW THAN THEY WERE PRIOR TO THE USE OF THE INTERGEL. I HAVE SPENT THOUSANDS OF DOLLARS TRYING TO TREAT MY PAIN SINCE USING THIS PRODUCT OVER THE PAST SEVERAL YEARS. DOSE OR AMOUNT: UNK, FREQUENCY: ONCE. DATES OF USE: 2002. DIAGNOSIS OR REASON FOR USE: PREVENTION OF PELVIC ADHESIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INTERGEL UNK MCN GYNECARE
    2 INTERGEL UNK MCN GYNECARE

    Patients

    Seq Age Sex Outcome Treatment
    1 33 YR Hospitalization| O