BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SURGIMESH

    MDR report key: 2903759 · Received January 2, 2013

    Report

    Report Number
    3005841068-2012-00004
    Event Type
    Injury
    Date Received
    January 2, 2013
    Date of Event
    December 5, 2012
    Report Date
    December 31, 2012
    Manufacturer
    ASPIDE MEDICAL, 246 ALLEE LAVOISIER
    Product Code
    FTL
    PMA / PMN Number
    K072974
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ID, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    ON (B)(6) 2012 THE PATIENT WAS OPERATED ON FOR AN UPPER RIGHT QUADRANT INCISIONAL HERNIA WHICH WAS REPAIRED WITH A SURGIMESH XB C-10 SUTURED IN USING ABSORBABLE 1-0 VICRYL SUTURE. OVER THE NEXT 9 MONTHS THE PATIENT HAD A SERIES OF SKIN RASH PROBLEMS THOUGHT TO BE CAUSED BY A POST OPERATIVE SKIN DRESSING. AT SEVERAL POINTS THE PATIENT WAS PUT ON ANTIBIOTICS WHICH CLEARED UP THE SKIN RASH. DURING THE SAME TIME PERIOD THE PATIENT HAD A BAD TOOTH WHICH EVENTUALLY BECAME INFECTED. FOLLOWING THE FINAL COURSE OF ANTIBIOTICS DURING (B)(6), A SMALL DRAINING SINUS FORMED AT THE PRIOR HERNIA INCISION REPAIR SITE. ON (B)(6) 2012 THE PATIENT WAS RE-OPERATED. UPON EXPLORATION A POCKET OF CHRONIC PUS/GRANULATION TISSUE WAS FOUND ABOVE THE XB-C10. THE SURGEON CHOSE TO REMOVE THE XB C-10 AND PROCEEDED TO DISSECT IT AWAY FROM THE SURROUNDING TISSUE FOR REMOVAL. THE PATIENTS RECOVERY WAS COMPLICATED BY POOR CARDIAC STATUS AND DEVELOPMENT OF A COLO-CUTANEOUS FISTULA. THE PATIENT WAS DISCHARGED FROM THE HOSPITAL ON (B)(6) 2012.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1039 SURGIMESH XB TINTRA FTL ASPIDE MEDICAL, 246 ALLEE LAVOISIER C-10 F05078A

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention