BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MESH - VENTRALEX

    MDR report key: 2232482 · Received August 25, 2011

    Report

    Report Number
    1213643-2011-00401
    Event Type
    Injury
    Date Received
    August 25, 2011
    Report Date
    August 10, 2011
    Manufacturer
    DAVOL INC
    Product Code
    FTL
    PMA / PMN Number
    K021736
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    BASED ON INFORMATION REPORTED TO DAVOL, A PT HAD A VENTRALEX MESH IMPLANTED. THE PT IS REPORTED TO HAVE DEVELOPED AN INFECTION THAT REQUIRED THE MESH TO BE REMOVED. CURRENTLY, IT IS UNK WHETHER THE DEVICE MAY HAVE CAUSED OR CONTRIBUTED TO THE ALLEGED EVENT. NO MEDICAL RECORDS OR PRODUCT LOT NUMBER HAS BEEN PROVIDED. WE HAVE CONTACTED THE INITIAL REPORTER TO OBTAIN ADDITIONAL INFORMATION AND REQUEST RETURN OF THE DEVICE FOR EVALUATION. THIS MDR INCLUDES ALL PT, EVENT AND DEVICE INFORMATION DAVOL HAS RECEIVED TO DATE.

    Description of Event or Problem · 1

    BASED ON INFORMATION REPORTED TO DAVOL: NI/NI/NI -- PT HAD A VENTRALEX MESH IMPLANTED. NI/NI/NI -- PT DEVELOPED AN INFECTION THAT REQUIRED MESH REMOVAL.

    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