BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROCEED MESH

    MDR report key: 8865938 · Received August 6, 2019

    Report

    Report Number
    2210968-2019-85213
    Event Type
    Injury
    Date Received
    August 6, 2019
    Report Date
    July 8, 2019
    Manufacturer
    ETHICON INC.
    Product Code
    FTL
    PMA / PMN Number
    K060713
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THIS REPORT IS RELATED TO A JOURNAL ARTICLE; THEREFORE, NO PRODUCT WILL BE RETURNED FOR ANALYSIS AND THE BATCH HISTORY RECORDS CANNOT BE REVIEWED AS THE LOT NUMBER HAS NOT BEEN PROVIDED. THE SINGLE COMPLAINT WAS REPORTED WITH MULTIPLE EVENTS. THERE ARE NO ADDITIONAL DETAILS REGARDING THE ADDITIONAL EVENTS. CITATION: HERNIA (2015); 19:845¿847.DOI 10.1007/S10029-013-1183-7. ATTEMPTS ARE BEING MADE TO OBTAIN THE FOLLOWING INFORMATION.  TO DATE NO RESPONSE HAS BEEN PROVIDED. IF FURTHER DETAILS ARE RECEIVED AT A LATER DATE A SUPPLEMENTAL MEDWATCH WILL BE SENT. WERE THE CASES DISCUSSED IN THIS ARTICLE PREVIOUSLY REPORTED TO ETHICON? IF YES, PLEASE PROVIDE A COMPLAINT REFERENCE NUMBER. DOES THE SURGEON BELIEVE THAT ETHICON PRODUCT (PROCEED MESH) INVOLVED CAUSED AND/OR CONTRIBUTED TO THE POST-OPERATIVE COMPLICATIONS DESCRIBED IN THE ARTICLE? DOES THE SURGEON BELIEVE THERE WAS ANY DEFICIENCY WITH THE ETHICON PRODUCT INVOLVED? (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED IN A JOURNAL ARTICLE WITH TITLE: SUCCESSFUL CONSERVATIVE TREATMENT OF A CANDIDA ALBICANS INTRAPERITONEAL MESH INFECTION FOLLOWING LAPAROSCOPIC VENTRAL HERNIA REPAIR. THE AUTHORS REPORTED A CASE OF A CANDIDA ALBICANS MESH INFECTION THAT WAS SUCCESSFULLY TREATED WITHOUT THE NEED FOR SURGICAL DEBRIDEMENT OR MESH REMOVAL. A (B)(6) YEAR OLD FEMALE PATIENT WAS ADMITTED WITH A LARGE INCARCERATED PARA-UMBILICAL HERNIA, CONTAINING MOST OF THE SMALL BOWEL AND TRANSVERSE COLON. THE PATIENT UNDERWENT EMERGENCY LAPAROSCOPIC REPAIR USING A 20X20 CM PROCEED COMPOSITE MESH (ETHICON). REPORTED COMPLICATIONS INCLUDED FLUCTUANT SWELLING AND ERYTHEMA OVER HER ABDOMINAL WOUND, SUPERFICIAL AND COMMUNICATING DEEP COLLECTION, BILOBED COLLECTION PROTRUDING THROUGH THE MIDLINE AND CONTAINING GAS SURROUNDING THE MESH, COMMUNICATING COLLECTIONS SUPERIOR TO THE BLADDER AND IN THE POUCH OF DOUGLAS IN WHICH AN ULTRASOUND-GUIDED PLACEMENT OF A DRAIN THAT PRODUCED SIGHTLY HEMORRHAGIC SEROUS FLUID CONTAINING A LARGE AMOUNT OF SMALL AIR BUBBLES AND FROTH RESEMBLING BEER, AND HEAVY GROWTH OF CANDIDA ALBICANS IN WHICH ORAL FLUCONAZOLE WAS COMMENCED AND THE CAVITY/MESH WAS IRRIGATED VIA PERCUTANEOUSLY INSERTED DRAIN USING A BAG OF NORMAL SALINE SOLUTION. THE PATIENT WAS DISCHARGED ON ORAL FLUCONAZOLE WITH AN OPEN APPOINTMENT TO ATTEND WHENEVER NEEDED. CT SCAN 6-MONTHS POST-TREATMENT SHOWED COMPLETE RESOLUTION OF ALL COLLECTIONS AND THE PATIENT REMAINS SYMPTOM-FREE AFTER 3 YEARS. IN CONCLUSION, IT IS POSSIBLE TO TREAT CANDIDA ALBICANS INFECTION OF INTRAPERITONEAL MESH WITHOUT THE NEED FOR SURGICAL DEBRIDEMENT OR MESH REMOVAL BY ANTIFUNGAL THERAPY AND REGULAR WASHOUTS ALONE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    661539 PROCEED MESH MESH, SURGICAL, POLYMERIC FTL ETHICON INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Required Intervention