BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROCEED MULTI-LAYER LAMINATE MESH

    MDR report key: 1141044 · Received August 27, 2008

    Report

    Report Number
    2210968-2008-00735
    Event Type
    Injury
    Date Received
    August 27, 2008
    Date of Event
    May 14, 2008
    Report Date
    July 28, 2008
    Manufacturer
    ETHICON, INC.
    Product Code
    FTL
    PMA / PMN Number
    K060713
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DATE SENT TO THE FDA: 08/27/08. ATRIAL FIBRILLATION WITH A RAPID VENTRICULAR RATE AND PNEUMONIA OCCURRED - CONCLUSION: THE SURGEON HAS INDICATED THAT THE PT'S POST OPERATIVE COMPLICATIONS WERE NOT PRODUCT RELATED BUT WERE POSSIBLY PROCEDURE RELATED. 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 MEDWATCH REPORTS BEING SUBMITTED AS TWO SEPARATE DEVICES WERE USED. SEE 2210968-2008-00734 FOR THE OTHER MEDWATCH. THE SAME PT IS REPRESENTED IN EACH MEDWATCH.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PT UNDERWENT A PRIMARY, BILATERAL, LAPAROSCOPIC INGUINAL HERNIA REPAIR PROCEDURE IN 2008, IN WHICH THE SURGICAL MESH WAS USED. DURING THIS PROCEDURE THE PT WAS PLACED UNDER GENERAL ANESTHESIA. POSTOPERATIVELY THE FOLLOWING DAY, THE PT DEVELOPED ATRIAL FIBRILLATION WITH A RAPID VENTRICULAR RATE AND HYPOTENSION. THE SAME DAY THE PT UNDERWENT A CARDIOVERSION PERFORMED BY THE CARDIOLOGY DEPT. THIS EVENT IS INDICATED AS RESOLVED TWO DAYS LATER. IN THE SAME MONTH, THE PT DEVELOPED PNEUMONIA AND WAS VENTILATOR DEPENDENT. THIS EVENT APPEARS TO HAVE BEEN OVER A FEW WEEKS AND THUS THE PT UNDERWENT A TRACHEOSTOMY AND THE PLACEMENT OF A PERCUTANEOUS GASTROSTOMY TUBE. THE PT WAS DISCHARGED FROM THE HOSP THE FOLLOWING MONTH. THIS EVENT IS LISTED AS ONGOING AT THE LAST CONTACT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PROCEED MULTI-LAYER LAMINATE MESH MESH, SURGICAL, POLYMERIC FTL ETHICON, INC. NA ZLG767

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Life Threatening| R