BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SUPRA MESH BIOSURGICAL COMPOSITE

    MDR report key: 340122 · Received June 28, 2001

    Report

    Report Number
    MW1022293
    Event Type
    Injury
    Date Received
    June 28, 2001
    Date of Event
    November 4, 2000
    Report Date
    May 9, 2001
    Manufacturer
    GENZYME SURGICAL PRODUCTS CORP
    Product Code
    FTL
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MA, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    THE PT WAS ADMITTED FOR ELECTIVE REPAIR OF INCISIONAL HERNIA AND PANICULECTOMY WITH SUPRA MESH AND ABDOMINAL SCAR REVISION. THE PT WAS BROUGHT BACK TO THE OPERATING ROOM THE NEXT DAY FOR AN INTRA-ABDOMINAL ABSCESS. THIS REPORT IS BASED ON THE PRELIMINARY INFO RECEIVED BY HOSP WHICH HOSP HAS NOT HAD THE OPPORTUNITY TO INVESTIGATE OR VERIFY PRIOR TO THE REPORTING DATE. HOSP HAS NOT CONCLUSIVELY DETERMINED THE CAUSE OF THIS EVENT. IN ADDITION, THE SUBMISSION OF THIS REPORT SHALL NOT BE CONSTRUED AS AN ADMISSION THAT A REPORTABLE EVENT HAS IN FACT OCCURRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    29451 SUPRA MESH BIOSURGICAL COMPOSITE MESH 4X8 FTL GENZYME SURGICAL PRODUCTS CORP * 441791

    Patients

    Seq Age Sex Outcome Treatment
    1 47 YR Hospitalization| R