BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MESH - VENTRALEX

    MDR report key: 2090031 · Received May 3, 2011

    Report

    Report Number
    1213643-2011-00200
    Event Type
    Injury
    Date Received
    May 3, 2011
    Date of Event
    February 16, 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

    IT WAS REPORTED TO DAVOL THAT A PATIENT UNDERWENT TREATMENT FOR A BOWEL OBSTRUCTION IN (B)(6) 2010. DURING THAT PROCEDURE, A VENTRALEX MESH WAS IMPLANTED. ONE YEAR POST IMPLANT, THE PATIENT WAS HOSPITALIZED FOR ABDOMINAL PAIN AND VOMITING. WHEN, AFTER 48 HOURS, THE CONDITION DID NOT IMPROVE, THE SURGEON PERFORMED A LAPAROTOMY. ADHESIONS TO THE VENTRALEX MESH WERE NOTED. THERE WAS A SECTION OF ADHESIONS THAT APPEARED TO BE RESPONSIBLE FOR THE OCCLUSION. CURRENTLY, IT IS UNKNOWN WHETHER THE MESH MAY HAVE CONTRIBUTED TO THE ALLEGED EVENT. NO SAMPLE HAS BEEN RETURNED FOR EVALUATION, NO MEDICAL RECORDS HAVE BEEN PROVIDED, AND NO SPECIFIC DEVICE FAILURE HAS BEEN ALLEGED. FURTHERMORE, ADHESIONS ARE LISTED IN THE PRODUCT'S INSTRUCTIONS FOR USE AS A POSSIBLE ADVERSE REACTION. WITH THE INFORMATION AVAILABLE, NO CONCLUSION CAN BE DRAWN AT THIS TIME.

    Description of Event or Problem · 1

    ON (B)(6) 2010 - PATIENT TREATED FOR A BOWEL OBSTRUCTION, A PROCEDURE THAT ALSO INCLUDED PLACEMENT OF A BARD VENTRALEX MESH IMPLANTED. ON (B)(6) 2011 - PATIENT HOSPITALIZED WITH ABDOMINAL PAIN AND VOMITING FOR 48 HOURS. LAPAROTOMY PERFORMED. ADHESIONS TO MESH FOUND. ONE SECTION OF ADHESIONS APPEARED TO BE RESPONSIBLE FOR AN OCCLUSION. MESH EXPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MESH - VENTRALEX FTL DAVOL INC. NA HUSI0453

    Patients

    Seq Age Sex Outcome Treatment
    1 89 YR Required Intervention