BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROCEED MULTI-LAYER LAMINATE MESH

    MDR report key: 1822005 · Received August 23, 2010

    Report

    Report Number
    2210968-2010-00962
    Event Type
    Injury
    Date Received
    August 23, 2010
    Report Date
    July 22, 2010
    Manufacturer
    ETHICON, INC.
    Product Code
    FTL
    PMA / PMN Number
    K060713
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4): CONCLUSION: NO CONCLUSION CAN BE DRAWN AT THIS TIME. SHOULD ADD'L INFO BE OBTAINED, A SUPPLEMENTAL 3500A FORM WILL BE SUBMITTED ACCORDINGLY. THIS IS ONE OF TWO MEDWATCHES BEING SUBMITTED AS TWO DEVICES WERE INVOLVED IN THIS EVENT. SEE ALSO MEDWATCH 2210968-2010-00961. THE SAME PATIENT IS REPRESENTED IN EACH MEDWATCH.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT UNDERWENT A HERNIA REPAIR PROCEDURE OF TWO HERNIAS IN 2010 AND MESH WAS IMPLANTED. AFTER GOING HOME, THE PATIENT COMPLAINED OF PAIN AND WOULDN'T EAT. THE PATIENT WAS TAKEN BACK TO THE HOSPITAL WHERE SHE UNDERWENT 8 HOURS OF EMERGENCY SURGERY. THE SURGICAL MESH USED BECAME ENTANGLED WHICH PERFORATED THE SMALL BOWEL IN FOUR PLACES. DURING THE SURGERY, THE SURGEON STATED IT WAS HARD TO DISTINGUISH WHAT WAS MUSCLE AND WHAT WAS BOWEL. HE "TEASED" OUT THE MESH AND THEN USED COMPRESSION FOR THE BLEEDING. AS OF (B)(6)2010, THE PATIENT WAS STILL IN THE HOSPITAL WITH THREE FISTULAS WHICH DRAIN FROM HER BELLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PROCEED MULTI-LAYER LAMINATE MESH MESH, SURGICAL, POLYMERIC FTL ETHICON, INC. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention