BEUDAMED
    FDA Adverse Event Death Summary report: N

    PHASIX ST MESH

    MDR report key: 11927300 · Received June 3, 2021

    Report

    Report Number
    1213643-2021-04211
    Event Type
    Death
    Date Received
    June 3, 2021
    Report Date
    June 3, 2021
    Manufacturer
    DAVOL INC., SUB. C.R. BARD, INC.
    Product Code
    OWT
    PMA / PMN Number
    K143380
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    NO CONCLUSIONS CAN BE MADE. THE PATIENT'S ATTORNEY ALLEGES ADVERSE PATIENT OUTCOME ASSOCIATED WITH THE HERNIA MESH USED TO TREAT THE PATIENT INCLUDING SUBSEQUENT SURGICAL INTERVENTION AND DEATH. NO MEDICAL RECORDS, AUTOPSY REPORT, OR DEATH CERTIFICATE HAVE BEEN PROVIDED. NO LOT NUMBER HAS BEEN PROVIDED; THEREFORE, A REVIEW OF THE MANUFACTURING RECORDS IS NOT POSSIBLE. THIS EMDR REPRESENTS THE BARD/DAVOL PHASIX ST MESH (DEVICE #2). AN ADDITIONAL EMDR WAS SUBMITTED TO REPRESENT THE BARD/DAVOL VENTRALIGHT ST MESH (DEVICE #1). SHOULD ADDITIONAL INFORMATION BE PROVIDED, A SUPPLEMENTAL EMDR WILL BE SUBMITTED.

    Description of Event or Problem · 1

    ATTORNEY ALLEGES THAT THE PATIENT UNDERWENT SURGERY FOR IMPLANT OF UNSPECIFIED BARD/DAVOL VENTRALIGHT ST AND PHASIX ST ON (B)(6) 2017. AS REPORTED, THE PLAINTIFF IS MAKING A CLAIM FOR AN ADVERSE PATIENT OUTCOME AGAINST BOTH DEVICES. ATTORNEY ALLEGES THAT THE PATIENT HAD SUBSEQUENT SURGICAL INTERVENTION DUE TO THE HERNIA MESH DEVICE AND WRONGFUL DEATH OF THE PATIENT. IT IS ALSO ALLEGED THAT THE PATIENT EXPERIENCED EMOTIONAL DISTRESS AND THE DEVICE WAS DEFECTIVE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    826745 PHASIX ST MESH SURGICAL MESH OWT DAVOL INC., SUB. C.R. BARD, INC. NA NI

    Patients

    Seq Age Sex Outcome Treatment
    1 Death| R