BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VENTRALEX ST

    MDR report key: 8613342 · Received May 15, 2019

    Report

    Report Number
    1213643-2019-03955
    Event Type
    Injury
    Date Received
    May 15, 2019
    Report Date
    May 15, 2019
    Manufacturer
    DAVOL INC., SUB. C.R. BARD, INC.
    Product Code
    FZH
    PMA / PMN Number
    K101928
    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 ST(DEVICE #1) MAY HAVE CAUSED OR CONTRIBUTED TO THE REPORTED EVENT. 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 ST(DEVICE #1). AN ADDITIONAL EMDR WAS SUBMITTED TO REPRESENT THE BARD/DAVOL VENTRALEX ST (DEVICE #2). NOT RETURNED.

    Description of Event or Problem · 1

    ATTORNEY ALLEGES THAT THE PATIENT UNDERWENT SURGERY DURING WHICH THE PATIENT WAS IMPLANTED WITH AN UNSPECIFIED BARD/DAVOL VENTRALEX ST (DEVICE #1 AND DEVICE #2) ON (B)(6) 2012 AND (B)(6) 2014. AS REPORTED, THE PATIENT IS MAKING A CLAIM FOR AN ADVERSE PATIENT OUTCOME AGAINST THE BARD/DAVOL VENTRALEX ST (DEVICES #1 AND #2). 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
    405544 VENTRALEX ST SURGICAL MESH FZH DAVOL INC., SUB. C.R. BARD, INC. NA NI

    Patients

    Seq Age Sex Outcome Treatment
    1 Disability