BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MESH - VENTRALEX

    MDR report key: 2061230 · Received April 11, 2011

    Report

    Report Number
    1213643-2011-00143
    Event Type
    Injury
    Date Received
    April 11, 2011
    Report Date
    March 18, 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
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    BASED ON THE INFO RECEIVED, PT HAD A BARD VENTRALEX MESH IMPLANTED. A CULTURE LATER CAME BACK THAT REVEALED (B)(6). HOWEVER, THE PHYSICIAN DID INDICATE THAT HE DOES NOT BELIEVE THE MESH PRODUCT IS RESPONSIBLE FOR INFECTION. ALTHOUGH, IT IS NOT BELIEVED TO BE THE SOURCE OF INFECTION, THE PHYSICIAN SAID, HE HAD THREE PTS PRESENT WITH INFECTION POST IMPLANT. THE PRODUCT'S INSTRUCTIONS FOR USE STATE THAT IF AN INFECTION DEVELOPS, TREAT IT AGGRESSIVELY. THE PROSTHESIS MAY NOT HAVE TO BE REMOVED. AN UNTREATED INFECTION, HOWEVER, MAY REQUIRE REMOVAL OF THE PROSTHESIS. A REVIEW OF THE MFG RECORDS, INCLUDING PAPERWORK VERIFYING THE PRODUCT'S STERILIZATION, WAS REVIEWED AND DID NOT FIND ANY EVIDENCE OF A MFG-RELATED CAUSE FOR THE ALLEGED EVENT. BASED ON THE INFO AVAILABLE, IT DOES NOT APPEAR THAT A DEVICE FAILURE OCCURRED. THIS MDR INCLUDES ALL PT, EVENT AND DEVICE INFO DAVOL HAS RECEIVED TO DATE. SEE MDR 1213643-2011-00145 AND MDR 1213643-2011-00146 FOR THE TWO OTHER CASES REFERENCED BY THE PHYSICIAN.

    Description of Event or Problem · 1

    ON (B)(6) 2001 - AT 36 HOURS POST IMPLANT OF A VENTRALEX MESH TO REPAIR A HERNIA, PT HAD A FEVER. ON (B)(6) 2011 - MESH EXPLANTED, CULTURE IDENTIFIED (B)(6).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MESH - VENTRALEX FTL DAVOL INC. NA HUTD1689

    Patients

    Seq Age Sex Outcome Treatment
    1 NI Required Intervention