BEUDAMED
    FDA Adverse Event Other Summary report: N

    SEPRAFILM (SODIUM HYALURONATE, CARBOXYMETHYLCELLULOSE) MEMBRANE

    MDR report key: 3027996 · Received March 27, 2013

    Report

    Report Number
    1220423-2013-00010
    Event Type
    Other
    Date Received
    March 27, 2013
    Report Date
    March 19, 2013
    Manufacturer
    GENZYME BIOSURGERY (SEPRAFILM/PACK)
    Product Code
    MCN
    PMA / PMN Number
    P950034
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    MFR'S COMMENT: AS ONLY LIMITED INFO HAS BEEN OBTAINED SO FAR, IT IS DIFFICULT TO ASSESS A CAUSE AND EFFECT RELATIONSHIP.

    Description of Event or Problem · 1

    PAST NEGATIVE REACTION [ADVERSE REACTION]. CASE DESCRIPTION: SPONTANEOUS REPORT WAS RECEIVED ON (B)(4) 2013 FROM AN ONCOLOGIST REGARDING A PT (DEMOGRAPHICS NOT PROVIDED), INITIALS UNK. THE PT'S MEDICAL HISTORY WAS NOT PROVIDED. ON AN UNSPECIFIED DATE, SEPRAFILM (SODIUM HYALURONATE, CARBOXYMETHYLCELLULOSE) MEMBRANE WAS PLACED (SITE AND NUMBER OF SHEETS NOT PROVIDED). THE LOT NUMBER OF SEPRAFILM WAS NOT PROVIDED. ON AN UNSPECIFIED DATE, THE PT HAD A NEGATIVE REACTION. IT WAS REPORTED THAT THE "SEPRAFILM LEFT BOARDER OF NEGATIVE REACTION WHERE IT WAS PLACED." IT WAS ALSO REPORTED THAT THE EVENT WAS VIEWED UPON SURGICAL RE-ENTRY OF THE PT. THE OUTCOME OF THE EVENT OF PAST NEGATIVE REACTION WAS NOT PROVIDED. RELEVANT CONCOMITANT MEDICATIONS WERE NOT PROVIDED. THE INTENSITY FOR THE EVENT WAS NOT PROVIDED. THE RELATIONSHIP BETWEEN SEPRAFILM AND THE EVENT WAS NOT PROVIDED BY THE REPORTING ONCOLOGIST.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    126767 SEPRAFILM (SODIUM HYALURONATE, CARBOXYMETHYLCELLULOSE) MEMBRANE BIORESORBABLE ADHESION BARRIER MCN GENZYME BIOSURGERY (SEPRAFILM/PACK) UNK UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention