BEUDAMED
    FDA Adverse Event Other Summary report: N

    SEPRAFILM (SODIUM HYALURONATE, CARBOXYMETHYLCELLULOSE) MEMBRANE

    MDR report key: 2556509 · Received April 26, 2012

    Report

    Report Number
    1220423-2012-00010
    Event Type
    Other
    Date Received
    April 26, 2012
    Date of Event
    March 7, 2012
    Report Date
    April 17, 2012
    Manufacturer
    GENZYME BIOSURGERY (SEPRAFILM/PACK)
    Product Code
    MCN
    PMA / PMN Number
    P950034
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    MFR'S COMMENT: THE BENEFIT-RISK RELATIONSHIP OF SEPRAFILM IS NOT AFFECTED BY THIS REPORT.

    Description of Event or Problem · 1

    RASHES [RASH]. SWELLING OF MOUTH [OEDEMA MOUTH]. DIFFICULTY BREATHING [DYSPNOEA]. CASE DESCRIPTION: SPONTANEOUS REPORT WAS RECEIVED ON (B)(4) 2012 FROM A PHYSICIAN VIA A COMPANY SALES REPRESENTATIVE REGARDING A FEMALE PATIENT, INITIALS (B)(6). THE PATIENT'S MEDICAL HISTORY WAS NOT PROVIDED. ON (B)(6) 2012, THE PATIENT UNDERWENT EXPLORATORY LAPAROTOMY WITH LYSIS OF ADHESIONS FOR SMALL BOWEL OBSTRUCTION. AT THE END OF THE SURGERY, SEPRAFILM WAS PLACED FOR POST-OPERATIVE ADHESIONS. WITHIN 12 HOURS OF THE OPERATION, THE PATIENT EXPERIENCED RASHES, SWELLING OF THE MOUTH, AND DIFFICULTY BREATHING. THE PATIENT WAS TREATED WITH IV STEROIDS AND BENADRYL (ROUTE OF ADMINISTRATION NOT PROVIDED). ALL PAIN MEDICATIONS AND ANTIBIOTICS WERE HELD. THE ACTION TAKEN WITH SEPRAFILM TREATMENT WAS NOT PROVIDED. THE OUTCOME OF THE EVENTS OF RASHES, SWELLING OF THE MOUTH, AND DIFFICULTY BREATHING WAS REPORTED BY PHYSICIAN AS: "THE PATIENT DOING WELL, DISCHARGED IN GOOD CONDITION ON POST OPERATIVE DAY # 8." CONCOMITANT MEDICATIONS WERE NOT PROVIDED. THE INTENSITY FOR THE EVENTS OF RASHES, SWELLING OF THE MOUTH, AND DIFFICULTY BREATHING WAS NOT PROVIDED. THE RELATIONSHIP BETWEEN SEPRAFILM AND THE EVENTS OF RASHES, SWELLING OF THE MOUTH, AND DIFFICULTY BREATHING WAS NOT PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SEPRAFILM (SODIUM HYALURONATE, CARBOXYMETHYLCELLULOSE) MEMBRANE BIORESORBABLE ADHESION BARRIER MCN GENZYME BIOSURGERY (SEPRAFILM/PACK) UNK UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention