BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MESH - VENTRALEX

    MDR report key: 2213046 · Received August 9, 2011

    Report

    Report Number
    1213643-2011-00370
    Event Type
    Injury
    Date Received
    August 9, 2011
    Report Date
    July 16, 2011
    Manufacturer
    DAVOL INC
    Product Code
    FTL
    PMA / PMN Number
    K021736
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    RI, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    BASED ON INFO REPORTED BY THE PT, AN UMBILICAL HERNIA WAS REPAIRED WITH A VENTRALEX MESH. THE PT ALLEGES THAT AN INFECTION DEVELOPED AND THAT THE MESH MUST BE REMOVED. WE HAVE CONTACTED THE INITIAL REPORTER TO REQUEST ADD'L INFO. THIS MDR INCLUDES ALL PT, EVENT AND DEVICE INFO DAVOL HAS RECEIVED TO DATE. CURRENTLY, IT IS UNK WHETHER THE DEVICE MAY HAVE CAUSED OR CONTRIBUTED TO THE EVENT. NO MEDICAL RECORDS OR LOT NUMBER HAVE BEEN PROVIDED, AND IT DOES NOT APPEAR THAT THE MESH WAS EXPLANTED. WITHOUT ADD'L INFO, NO CONCLUSION CAN BE DRAWN.

    Description of Event or Problem · 1

    BASED ON INFO REPORTED TO DAVOL BY THE PT: (B)(6) 2008: PT UNDERWENT OPEN UMBILICAL REPAIR WITH VENTRALEX MESH. THE PT ALLEGES UMBILICAL HERNIA IS INFECTED AND MESH MUST BE REMOVED.

    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