BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROCEED* MULTI-LAYER LAMINATE MESH

    MDR report key: 2063302 · Received April 19, 2011

    Report

    Report Number
    2210968-2011-00438
    Event Type
    Injury
    Date Received
    April 19, 2011
    Date of Event
    March 18, 2011
    Report Date
    March 25, 2011
    Manufacturer
    ETHICON
    Product Code
    FTL
    PMA / PMN Number
    K060713
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). BLEEDING OCCURRED. CONCLUSION: THE PRODUCT UPON WHICH THIS MEDWATCH IS BASED IS ANTICIPATED. ONCE THE PRODUCT IS RECEIVED, ANY FURTHER INFORMATION DERIVED FROM THE EVALUATION WILL BE SUBMITTED IN A SUPPLEMENTAL 3500A FORM.

    Additional Manufacturer Narrative · 1

    (B)(4). THE PATIENT (B)(6) SYMPTOMS REGARDING THE POSTOPERATIVE BLOOD LOSS WERE BLOOD LOSS MORE THAN DRAINAGE AND HEMOGLOBIN DROPPED. THERE WAS NO INSTABILITY OF CIRCULATION. THE PATIENT (B)(6) REOPERATION WAS INITIALLY LAPAROSCOPIC, BUT WAS THEN CONVERTED TO AN OPEN PROCEDURE DUE TO UNCONTROLLED BLEEDING AND PROBLEMS WITH THE MESH SEPARATING. THERE WAS NO INDICATION OF DAMAGE TO THE MESH CAUSED BY THE SECOND LAPAROSCOPY. THE COMPLETE DELAMINATION OF THE CELLULOSE OF THE MESH WAS VISIBLE DIRECTLY AFTER INSERTION OF THE LAPAROSCOPE. THE SURGEON OPINED THAT THE MESH WAS NOT THE CAUSE THE POSTOPERATIVE BLEEDING. CURRENTLY THE PATIENT IS FREE OF SYMPTOMS. RESULTS: ONE PIECE OF EXPLANTED MESH INVOLVED IN THIS EVENT WAS RETURNED FOR EVALUATION. THE MESH WAS EXAMINED VISUALLY AND UNDER A STEREOMICROSCOPE. THE ORC LAYER WAS COMPLETELY DELAMINATED AND IN A SEPARATE BAG AS NUMEROUS SMALL PIECES. NO SIGNIFICANT DAMAGE WAS FOUND. CONCLUSION: NO CONCLUSION CAN BE DRAWN AT THIS TIME. SHOULD ADDITIONAL INFORMATION BE OBTAINED, A SUPPLEMENTAL 3500A FORM WILL BE SUBMITTED ACCORDINGLY. IN ADDITION, A REVIEW OF THE BATCH MANUFACTURING RECORDS WAS CONDUCTED AND THE BATCH MET ALL FINISHED GOODS RELEASE CRITERIA.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT UNDERWENT A SURGICAL PROCEDURE ON (B)(6) 2011 FOR AN INTRAPERITONEAL HERNIA REPAIR AND MESH WAS USED. THE PATIENT EXPERIENCED BLEEDING OF THE ABDOMINAL WALL TWELVE HOURS AFTER THE INITIAL PROCEDURE. A SECOND PROCEDURE WAS DONE. DURING THE SECOND PROCEDURE, THE PHYSICIAN NOTED THAT THE CELLULOSE LAYER OF THE MESH HAD SEPARATED. WHEN THE PHYSICIAN WENT TO SUCTION THE BLOOD, THE CELLULOSE STUCK TO THE SUCTION DEVICE AND IT DISINTEGRATED INTO PIECES. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PROCEED* MULTI-LAYER LAMINATE MESH MESH, SURGICAL, POLYMERIC FTL ETHICON NA CKG487

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Required Intervention