BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MESH ¿ VENTRALEX

    MDR report key: 9516526 · Received December 24, 2019

    Report

    Report Number
    1213643-2019-12499
    Event Type
    Injury
    Date Received
    December 24, 2019
    Date of Event
    February 4, 2018
    Report Date
    December 24, 2019
    Manufacturer
    DAVOL INC., SUB. C.R. BARD, INC.
    Product Code
    FTL
    UDI-DI
    00801741000355
    PMA / PMN Number
    K024008
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    RI, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    AT THIS TIME NO CONCLUSIONS CAN BE MADE. THE PATIENT'S ATTORNEY ALLEGES PAST, PRESENT AND FUTURE DAMAGES, PAIN AND SUFFERING, PERMANENT INJURY AND SURGICAL INTERVENTION, HOWEVER, NO DETAILS HAVE BEEN PROVIDED. NO MANUFACTURING ISSUES ASSOCIATED TO THE REPORTED EVENT WERE FOUND IN THE REVIEWED LOT. DHR REVIEW SHOWED COMPONENT ACCEPTABILITY AND TRACEABILITY WERE CONFIRMED THROUGH INCOMING INSPECTION RECORDS FOR TRACEABLE COMPONENTS USED. ALL PROCESS STEPS WERE COMPLETED PER MANUFACTURING PROCEDURES, INSPECTION PROCEDURES, AS DOCUMENTED IN WORKORDER AND LOT HISTORY RECORDS. PRODUCT PASSED ALL REQUIRED INSPECTIONS AT BOTH END PRODUCT AND SUBASSEMBLY LEVELS. NO DEVICE FAILURE MODES ASSOCIATED TO THE REPORTED EVENT WERE FOUND. SHOULD ADDITIONAL INFORMATION BE PROVIDED A SUPPLEMENTAL EMDR WILL BE SUBMITTED. NOT RETURNED.

    Description of Event or Problem · 1

    ATTORNEY ALLEGES THAT THE PATIENT UNDERWENT SURGERY FOR IMPLANT OF AN UNSPECIFIED NON BARD/DAVOL PRODUCT ON (B)(6) 2012 AND BARD/DAVOL VENTRALEX DEVICE (REF. NO. 0010301, LOT NO. HUZC1879) WAS PLACED ON (B)(6) 2015 DUE TO THE RECURRENCE OF THE HERNIA DEFECT. AS REPORTED, THE PATIENT IS MAKING A CLAIM FOR AN ADVERSE PATIENT OUTCOME AGAINST THE VENTRALEX DEVICE. ATTORNEY ALLEGES THAT THE PATIENT UNDERWENT SURGERY FOR THE REMOVAL OF THE HERNIA MESH PRODUCTS ON (B)(6) 2018. ATTORNEY ALLEGES GENERAL ALLEGATIONS FOR "PAST, PRESENT, AND FUTURE DAMAGES, INCLUDING BUT NOT LIMITED TO, MENTAL AND PHYSICAL PAIN AND SUFFERING FOR SEVERE AND PERMANENT PERSONAL INJURIES SUSTAINED BY THE PATIENT." ATTORNEY ALLEGES THAT THE PATIENT HAD SUBSEQUENT SURGICAL INTERVENTION DUE TO THE HERNIA MESH DEVICE. ATTORNEY ALLEGES THAT THE PATIENT EXPERIENCED EMOTIONAL DISTRESS AND THE DEVICE WAS DEFECTIVE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1311800 MESH ¿ VENTRALEX SURGICAL MESH FTL DAVOL INC., SUB. C.R. BARD, INC. NA HUZC1879 00801741000355

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention| S