BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MESH - VENTRALEX

    MDR report key: 2120270 · Received May 31, 2011

    Report

    Report Number
    1213643-2011-00241
    Event Type
    Injury
    Date Received
    May 31, 2011
    Report Date
    May 9, 2011
    Manufacturer
    DAVOL INC.
    Product Code
    FTL
    PMA / PMN Number
    K021736
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    BASED ON INFO RECEIVED FROM THE OPERATING ROOM NURSE, THE PT DEVELOPED A POST OP INFECTION 10 DAYS AFTER HAVING A VENTRALEX GRAFT IMPLANTED. THE PT REPORTEDLY HAD THE INCISION DRAINED, AND THEN HAD THE MESH EXPLANTED. IT WAS REPORTED THAT THE MESH WAS BLACK AND THAT THE PT DEVELOPED A POST-OPERATIVE INFECTION. WHILE THERE IS NO INDICATION THE REPORTED POST-OPERATIVE INFECTION WAS RELATED TO THE MESH, INFECTION IS LISTED AS A POSSIBLE ADVERSE REACTION IN THE PRODUCT'S INSTRUCTIONS FOR USE. THE IFU STATES THAT IF AN INFECTION DEVELOPS, TREAT IT AGGRESSIVELY. WE HAVE CONTACTED THE INITIAL REPORTER TO REQUEST ADDITIONAL INFO AND TO REQUEST RETURN OF THE DEVICE FOR EVALUATION. THIS MDR INCLUDES ALL PT, EVENT AND DEVICE INFO DAVOL HAS RECEIVED TO DATE. WITH THE INFO CURRENTLY AVAILABLE, NO CONCLUSION CAN BE DRAWN.

    Description of Event or Problem · 1

    BASED ON INFO REPORTED BY OPERATING ROOM RN: IN 2011 -- PT HAD A VENTRALEX MESH IMPLANTED. IT WAS REPORTED THAT 10 DAYS AFTER IMPLANT, THE PT HAD A POST-OP INFECTION. INCISION WAS DRAINED, BUT MESH HAD TO BE REMOVED SURGICALLY. THE MESH APPEARED TO BE BLACK.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 NI Required Intervention