BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VENTRALEX

    MDR report key: 8664100 · Received June 3, 2019

    Report

    Report Number
    1213643-2019-04551
    Event Type
    Injury
    Date Received
    June 3, 2019
    Date of Event
    December 9, 2011
    Report Date
    March 25, 2026
    Manufacturer
    DAVOL INC., SUB. C.R. BARD, INC.
    Product Code
    FTL
    PMA / PMN Number
    K132441
    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 TO WHAT EXTENT THE BARD/DAVOL VENTRALEX (DEVICE #1) MAY HAVE CAUSED OR CONTRIBUTED TO THE REPORTED EVENT. THE PATIENT'S ATTORNEY ALLEGES INJURIES AND REVISION SURGERY; HOWEVER, NO DETAILS HAVE BEEN PROVIDED. THE CAUSE OF THE PATIENT POSTOPERATIVE COMPLICATIONS CANNOT BE DETERMINED AT THIS TIME. NO LOT NUMBER HAS BEEN PROVIDED THEREFORE A REVIEW OF THE MANUFACTURING RECORDS IS NOT POSSIBLE AT THIS TIME. INFORMATION IS LIMITED. SHOULD ADDITIONAL INFORMATION BE PROVIDED A SUPPLEMENTAL EMDR WILL BE SUBMITTED. THIS EMDR REPRESENTS THE BARD/DAVOL VENTRALEX (DEVICE #1).THERE IS NO ALLEGATION RELATED TO THE BARD/DAVOL VENTRALIGHT ST. NOT RETURNED.

    Description of Event or Problem · 1

    ATTORNEY ALLEGES THAT THE PATIENT UNDERWENT SURGERY FOR IMPLANT OF AN UNSPECIFIED BARD/DAVOL VENTRALEX(DEVICE #1) AND AN UNSPECIFIED VENTRALIGHT ST ON (B)(6) 2009 OR (B)(6) 2010 OR (B)(6) 2015. IT IS ALSO ALLEGED BY PATIENT'S ATTORNEY THAT ON (B)(6) 2011 AND (B)(6) 2015, THE PATIENT HAD UNSPECIFIED INJURIES RELATED TO A DEFECT IN THE VENTRALEX(DEVICE #1), AND UNDERWENT REVISION SURGERY. AS REPORTED, THE PATIENT IS MAKING A CLAIM FOR AN ADVERSE PATIENT OUTCOME AGAINST THE VENTRALEX (DEVICE #1). AS REPORTED, THE 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.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    455801 VENTRALEX SURGICAL MESH FTL DAVOL INC., SUB. C.R. BARD, INC. NA NI

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention| S