BEUDAMED
    FDA Adverse Event Summary report: N

    SEPRAFILM (SODIUM HYALURONATE, CARBOXYMETHYLCELLULOSE) MEMBRANE

    MDR report key: 1942492 · Received November 23, 2010

    Report

    Report Number
    1220423-2010-00026
    Date Received
    November 23, 2010
    Report Date
    November 12, 2010
    Manufacturer
    GENZYME BIOSURGERY (SEPRAFILM/PACK)
    Product Code
    MCN
    PMA / PMN Number
    PMA P950034
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NV, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    POST-OPERATION ABSCESS [POSTOPERATIVE ABSCESS]. CASE DESCRIPTION: A SPONTANEOUS REPORT WAS RECEIVED ON (B)(6) 2010 FROM AN HCP VIA A COMPANY REP REGARDING A PT, NAME AND AGE NOT KNOWN, WHO EXPERIENCED A POST-OPERATION ABSCESS AFTER THEY RECEIVED SEPRAFILM. THE COMPANY REP RECEIVED INFO FROM AN UNSPECIFIED PERSON AT THE HCP'S OFFICE. ACCORDING TO THE INFORMANT, THE HCP STATED THAT THE PT HAD EXPERIENCED A POST-OPERATIVE ABSCESS. NO FURTHER INFO IS AVAILABLE AT THIS TIME. FOR OTHER SIMILAR ADVERSE EVENTS REPORTED BY THIS REPORTER, PLEASE REFER TO MFR CONTROL NUMBER (B)(4). THE BENEFIT-RISK RELATIONSHIP OF SEPRAFILM IS NOT AFFECTED BY THIS REPORT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other