BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MESH - VENTRALEX

    MDR report key: 2090015 · Received May 3, 2011

    Report

    Report Number
    1213643-2011-00199
    Event Type
    Injury
    Date Received
    May 3, 2011
    Date of Event
    April 5, 2011
    Report Date
    April 13, 2011
    Manufacturer
    DAVOL INC.
    Product Code
    FTL
    PMA / PMN Number
    K021736
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHARMACIST

    Narratives

    Additional Manufacturer Narrative · 1

    ACCORDING TO INFORMATION REPORTED TO DAVOL, A VENTRALEX MESH WAS USED TO REPAIR THE PATIENT'S RECURRENT UMBILICAL HERNIA ON (B)(6) 2011. THAT MESH WAS SAID TO BE EXPLANTED ON (B)(6) 2011 AFTER THE MESH ALLEGEDLY BECAME ADHERENT TO A LOOP OF THE SMALL BOWEL. CURRENTLY, IT IS UNKNOWN WHETHER THE DEVICE MAY HAVE CAUSED OR CONTRIBUTED TO THE ALLEGED EVENT. NO SAMPLE HAS BEEN RETURNED FOR EVALUATION AND NO MEDICAL RECORDS HAVE BEEN PROVIDED. A MANUFACTURING REVIEW WAS PERFORMED AND THERE WAS NO EVIDENCE OF ANY MANUFACTURING-RELATED ISSUES. WITH THE INFORMATION CURRENTLY AVAILABLE, NO CONCLUSION CAN BE DRAWN AT THIS TIME.

    Description of Event or Problem · 1

    ON (B)(6) 2011 - BARD VENTRALEX IMPLANTED TO REPAIR RECURRENCE OF UMBILICAL HERNIA. ON (B)(6) 2011 - SURGICAL INTERVENTION WAS NECESSARY FOR AN OCCLUSION (BOWEL OBSTRUCTION) DUE TO AN ADHESION WITH THE MESH. MESH EXPLANTED. HERNIA REPAIR PERFORMED WITH SUTURES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MESH - VENTRALEX FTL DAVOL INC. NA HUUH0491

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Required Intervention