BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MESH - VENTRALEX

    MDR report key: 2232492 · Received August 25, 2011

    Report

    Report Number
    1213643-2011-00400
    Event Type
    Injury
    Date Received
    August 25, 2011
    Date of Event
    July 29, 2011
    Report Date
    August 1, 2011
    Manufacturer
    DAVOL INC
    Product Code
    FTL
    PMA / PMN Number
    K021736
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    BASED ON THE INFORMATION REPORTED TO DAVOL, THE PT UNDERWENT SURGERY ON (B)(6) 2001 THAT INCLUDED EXPLANT OF A VENTRLEX MESH. THE SURGEON IS SAID TO HAVE NOTED THAT THE MESH APPEARED "CRUMPLED" PRIOR TO EXPLANT. CURRENTLY, IT IS UNK WHETHER THE DEVICE MAY HAVE CAUSED OR CONTRIBUTED TO THE ALLEGED EVEN. NO MEDICAL RECORDS HAVE BEEN PROVIDED AND NO SAMPLE HAS BEEN RETURNED FOR EVALUATION. WE HAVE CONTACTED THE INITIAL REPORTER TO REQUEST ADDITIONAL INFORMATION AND TO REQUEST RETURN OF THE DEVICE. 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: ON (B)(6) 2011 -- PT UNDERWENT SURGERY THAT INVOLVED THE EXPLANT OF VENTRALEX MESH. THE SURGEON REPORTED THAT HE OBSERVED THE MESH TO BE "CRUMPLED" PRIOR TO EXPLANT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MESH - VENTRALEX FTL DAVOL INC NA HUUE1403

    Patients

    Seq Age Sex Outcome Treatment
    1 NI Required Intervention