BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MESH - VENTRALEX

    MDR report key: 3833459 · Received May 20, 2014

    Report

    Report Number
    1213643-2014-00154
    Event Type
    Injury
    Date Received
    May 20, 2014
    Date of Event
    April 2, 2014
    Report Date
    April 22, 2014
    Manufacturer
    DAVOL INC., SUB. C.R. BARD, INC.
    Product Code
    FTL
    PMA / PMN Number
    K021736
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    SURGEON REPORTS THE PT HAD NO COMORBIDITIES ONLY ADIPOSITIES WHICH WOULD NOT RESULT IN THE PROBLEM EXPERIENCED. THE IMPLANT FIXATED WITH NON ABSORBABLE SUTURE. SURGEON CONFIRMED THAT THE IMPLANT DID NOT ERODE OR MIGRATE AFTER PLACEMENT. ALSO CONFIRMED THAT THERE WAS NO BOWEL ADHESION, DURING THE REVISION SURGERY HE FOUND THE BOWEL WAS INJURED AND INTESTINAL CONTENTS LEAKED IN THE ABDOMINAL CAVITY. THE MESH THAT WAS REMOVED WAS REPORTED TO BE INTACT WITH NO VISABLE DAMAGE. THE SURGEON DID NOT BELIEVE THAT THE BOWEL HAD BEEN DAMAGED DURING THE IMPLANT PROCEDURE BY SOMETHING OTHER THAN THE IMPLANT. THE DAVOL DEVICE IN QUESTION WAS DISCARDED BY THE FACILITY, THEREFORE WE ARE UNABLE TO PERFORM AN EVAL TO DETERMINE WHETHER THE DEVICE COULD HAVE CAUSED OR CONTRIBUTED TO THE REPORTED PT ADVERSE EVENT. A REVIEW OF THE DEVICE HISTORY RECORDS (DHR) FOR THIS PRODUCTION LOT WAS CONDUCTED AND NO ANOMALIES WERE FOUND. BASED ON THE REPORTED INFO, AND THE FACT THAT THE SAMPLE WAS DISCARDED, NO DEFINITIVE CONCLUSIONS CAN BE MADE.

    Description of Event or Problem · 1

    THE FOLLOWING WAS REPORTED BY THE PATIENT'S SURGEON: ON (B)(6) 2014 DURING AN OPEN PROCEDURE THE PT WAS IMPLANTED WITH A CENTRALEX PATCH FOR TREATMENT OF A HERNIA. THE PATCH WAS FIXED WITH NON ABSORBABLE SUTURE MATERIAL. ON (B)(6) 2014 THE SURGEON REPORTS THAT THE MESH CAUSED A BOWEL PERFORATION AND THE MESH WAS EXPLANTED. THE SURGEON REPORTS THAT UPON EXPLANT THE MESH WAS INTACT AND HAD NO VISIBLE DAMAGE. HE REPORTS THAT IT HAD NOT MIGRATED, NOR WERE THERE ANY MESH ADHESIONS TO THE BOWEL. THE MESH WAS DISCARDED BY THE USER FACILITY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    298683 MESH - VENTRALEX FTL DAVOL INC., SUB. C.R. BARD, INC. NA HUXK0345

    Patients

    Seq Age Sex Outcome Treatment
    1 36 YR Life Threatening| R