BEUDAMED
    FDA Adverse Event Other Summary report: N

    SEPRAFILM (SODIUM HYALURONATE, CARBOXYMETHYLCELLULOSE) MEMBRANE

    MDR report key: 2573877 · Received May 4, 2012

    Report

    Report Number
    1220423-2012-00011
    Event Type
    Other
    Date Received
    May 4, 2012
    Report Date
    April 30, 2012
    Manufacturer
    GENZYME BIOSURGERY (SEPRAFILM/PACK)
    Product Code
    MCN
    PMA / PMN Number
    P950034
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    MFR'S COMMENT: THE BENEFIT-RISK RELATIONSHIP OF THE PRODUCT IS NOT AFFECTED BY THIS REPORT. REPORT SOURCE LITERATURE DESCRIPTION: JOURNAL: BRITISH JOURNAL OF ANAESTHESIA. AUTHOR: KAWANISHI M., KOH J., ESAKI Y., KAWABATA M., OHISHI M. TITLE: ANAPHYLAXIS SHOCK PROBABLY INDUCED BY SEPRAFILM (SODIUM HYALURONATE-BASED BIORESORBABLE MEMBRANE). VOLUME: 108. YR: 2012. PAGES: 211-212.

    Description of Event or Problem · 1

    ANAPHYLAXIS SHOCK [ANAPHYLACTIC SHOCK]. CASE DESCRIPTION: LITERATURE-SPONTANEOUS REPORT WAS RECEIVED ON (B)(6) 2012 ENTITLED "ANAPHYLAXIS SHOCK PROBABLY INDUCED BY SEPRAFILM (SODIUM HYALURONATE-BASED BIORESORBABLE MEMBRANE)" REGARDING A (B)(6) FEMALE PT, INITIALS UNK. THE PT'S MEDICAL HISTORY WAS SIGNIFICANT FOR SEVERE ATOPIC DERMATITIS FOR OVER 20 YRS AND BROWN PIGMENTATION ON ALL EXTREMITIES AND BACK SKIN. FOR THE FIRST CESAREAN SECTION, SEPRAFILM WAS NOT USED DURING OPERATION. THE PT'S PREGNANT TERM WAS 37 MONTHS. ON AN UNSPECIFIED DATE, THE PT INITIATED SEPRAFILM MEMBRANE (DOSE REGIMEN NOT PROVIDED). ANESTHESIA WAS MAINTAINED MAINLY BY SPINAL ANESTHESIA AND PROPOFOL WAS STARTED FOR SEDATION SHORTLY AFTER THE BABY DELIVERY. CIRCULATORY CONDITION WAS CHECKED EVERY 5 MINUTE UNDER SPONTANEOUS RESPIRATION AND CIRCULATORY AND RESPIRATORY CONDITIONS WERE STEADILY MAINTAINED, BUT AT THE TIME OF SKIN SUTURING, THE PT'S RESPIRATORY RATE WAS INCREASED AND SHE MOVED HER UPPER EXTREMITIES. THE PULSE RATE WAS INCREASED TO 140 BEATS/MINUTE AND BLOOD PRESSURE WAS DEPRESSED TO 50MMHG. AMNIOTIC FLUID EMBOLISM WAS FIRST SUSPECTED, BUT ARTERIAL BLOOD ANALYSIS SHOWED NO RESPIRATORY DISTRESS DATA, PAO2 395MMHG AND PACO2 30MMHG. BLOOD BLEEDING INTO ABDOMINAL SPACE WAS ALSO SUSPECTED, BUT ECHO EXAM REVEALED NO BLEEDING AROUND THE UTERUS. LATEX CATHETER WAS REMOVED FROM THE BLADDER FOR LATEX ANAPHYLAXIS, BUT NO RECOVERY WAS NOTICED. THE PT'S PERIPHERAL BLOOD EXAMINATION SHOWED CONCENTRATED BLOOD, HAEMOGLOBIN INCREASED FROM PREOPERATIVE 10G/DL TO 14.5 G/DL. CIRCULATORY RECOVERY WAS OBTAINED BY THE ADMINISTRATION OF ADRENALIN 0.05 MG AND HYDROCORTISONE 500 MG. IT WAS REPORTED THAT AMNIOTIC FLUID ANALYSIS WAS ALSO THE POSSIBLE CAUSE FOR THE PT AND SHOCK OCCURRENCE, BUT THE TIMING OF SEPRAFILM APPLICATION WAS A KEY POINT. THE ACTION TAKEN WITH SEPRAFILM TREATMENT WAS NOT PROVIDED. THE OUTCOME FOR THE EVENT OF ANAPHYLAXIS SHOCK WAS UNK. THE INTENSITY FOR THE EVENT OF ANAPHYLAXIS SHOCK WAS ASSESSED AS UNK. THE REPORTER ASSESSED THE RELATIONSHIP BETWEEN SEPRAFILM AND THE EVENT OF ANAPHYLAXIS SHOCK AS PROBABLE.

    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 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 29 YR Required Intervention PROPOFOL (PROPOFOL) UNK| ANAESTHETICS UNK