BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MESH-VENTRALEX

    MDR report key: 2436317 · Received January 19, 2012

    Report

    Report Number
    1213643-2012-00033
    Event Type
    Malfunction
    Date Received
    January 19, 2012
    Date of Event
    December 16, 2011
    Report Date
    December 21, 2011
    Manufacturer
    DAVOL INC
    Product Code
    FTL
    PMA / PMN Number
    K021736
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    IT WAS REPORTED THAT THE RECOIL RING OF THE VENTRALEX MESH WAS BENT. CURRENTLY, WE ARE UNABLE TO DETERMINE THE CONDITION OF THE MESH AS IT WAS RECEIVED BY THE USER FACILITY OR WHAT MAY HAVE CAUSED THE REPORTED BEND. NO SAMPLE HAS BEEN RETURNED AND NO PHOTOGRAPHS OF THE MESH HAVE BEEN PROVIDED. A MANUFACTURING REVIEW WAS PERFORMED AND DID NOT FIND EVIDENCE OF A MANUFACTURING RELATED CAUSE FOR THE REPORTED CONDITION OF THE MESH. IT WAS ALSO REPORTED THAT THE PT HAD DEVELOPED MENTAL ADHESIONS TO THE MESH. ADHESIONS ARE LISTED AS A POSSIBLE ADVERSE REACTION IN THE PRODUCT'S INSTRUCTIONS FOR USE. IF ADDITIONAL INFORMATION IS RECEIVED, A FOLLOWUP MDR WILL BE SUBMITTED.

    Description of Event or Problem · 1

    BASED ON INFORMATION REPORTED TO DAVOL: (B)(6) 2011 - IT WAS REPORTED THAT THE MEMORY RECOIL RING WAS BENT AND THAT IT HAD TO BE REMOVED FROM THE PT DURING THE PROCEDURE. THERE WAS NO REPORT PT INJURY AND THE PROCEDURE WAS COMPLETED WITH ANOTHER VENTRALEX MESH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MESH-VENTRALEX FTL DAVOL INC NA HUVC1714

    Patients

    Seq Age Sex Outcome Treatment
    1 NI