BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROCEED VENTRAL PATCH UNKNOWN PRODUCT

    MDR report key: 8801052 · Received July 17, 2019

    Report

    Report Number
    2210968-2019-84433
    Event Type
    Injury
    Date Received
    July 17, 2019
    Report Date
    June 17, 2019
    Manufacturer
    ETHICON INC.
    Product Code
    FTL
    PMA / PMN Number
    K061533
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BE
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT COMPLAINT # (B)(4). TO DATE NO RESPONSE HAS BEEN PROVIDED. IF FURTHER DETAILS ARE RECEIVED AT A LATER DATE A SUPPLEMENTAL MEDWATCH WILL BE SENT. THE SINGLE COMPLAINT WAS REPORTED WITH MULTIPLE EVENTS. THERE ARE NO ADDITIONAL DETAILS REGARDING THE ADDITIONAL EVENTS. CITATION: HERNIA (2011) 15:463¿468; DOI 10.1007/S10029-010-0692-X. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED IN A JOURNAL ARTICLE WITH TITLE: COMPLICATIONS OF MESH DEVICES FOR INTRAPERITONEAL UMBILICAL HERNIA REPAIR: A WORD OF CAUTION. THIS STUDY AIMED TO PRESENT THREE CASES OF LATE COMPLICATIONS OBSERVED IN PATIENTS WHERE A DUAL LAYER MESH DEVICE WAS USED TO REPAIR AN UMBILICAL HERNIA. A (B)(6) YEAR OLD FEMALE PATIENT WITH SMALL UMBILICAL HERNIA UNDERWENT REPAIR USING PROCEED VENTRAL PATCH (PVP) WITH A DIAMETER OF 6.4 CM. THE MESH WAS PLACED IN THE INTRAPERITONEAL POSITION AS PRE-PERITONEAL PLANE WAS NOT POSSIBLE DUE TO SCARRING AROUND UMBILICUS. AFTER 5 MONTHS, THIS PATIENT HAD RECURRENCE OF HER UMBILICAL HERNIA AND ALSO DEVELOPED SECOND HERNIA AT EPIGASTRIC TROCAR SITE OF THE CHOLECYSTECTOMY. DURING LAPAROSCOPY, SOME OMENTAL ADHESIONS WERE PRESENT AT THE UMBILICUS, COVERING MESH. ON BOTH SIDES OF THE MESH, A RECURRENT JUXTA-UMBILICAL HERNIA WAS PRESENT. AFTER THE RELEASE OF THE OMENTAL ADHESIONS, THE MESH WAS FOUND TO HAVE SHRUNK AND FOLDED UP, TO A DIMENSION OF APPROXIMATELY 3.0 CM IN DIAMETER. THE MESH WAS REMOVED AND THE HERNIAS WERE EVALUATED. BOTH HERNIAS WERE REPAIRED USING AN EPTFE MESH (DUALMESH) OF 30CMX18CM, FIXED TO THE ABDOMINAL WALL WITH SPIRAL TACKERS (PROTACK) IN A DOUBLE CROWN CONFIGURATION. MESH DEVICES SHOULD BE USED TO REPAIR SMALL VENTRAL HERNIAS ONLY WHEN PATIENTS ARE ENTERED IN A PROSPECTIVE REGISTRY AND FOLLOW UP PROGRAM OR IN CLINICAL TRIALS, AT LEAST UNTIL STUDIES ARE PUBLISHED WITH A SUFFICIENT SAMPLE OF PATIENTS, AN ACCEPTABLE FOLLOW UP TIME, AND FAVOURABLE OUTCOMES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    594067 PROCEED VENTRAL PATCH UNKNOWN PRODUCT MESH, SURGICAL, POLYMERIC FTL ETHICON INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention