BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PHASIX ST MESH

    MDR report key: 12914901 · Received December 2, 2021

    Report

    Report Number
    1213643-2021-09034
    Event Type
    Injury
    Date Received
    December 2, 2021
    Report Date
    December 2, 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
    TX, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    NO CONCLUSIONS CAN BE MADE. THE PATIENT'S ATTORNEY ALLEGES ADVERSE PATIENT OUTCOME ASSOCIATED WITH THE HERNIA MESH USED TO TREAT THE PATIENT. THE PATIENT'S ATTORNEY ALLEGES THAT THE PATIENT HAD SUBSEQUENT SURGICAL INTERVENTION; HOWEVER, NO DETAILS 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 (DEVICE #4). ADDITIONAL EMDRS WERE SUBMITTED TO REPRESENT THE BARD/DAVOL VENTRALEX (DEVICE #1) AND THE BARD/DAVOL COMPOSIX L/P (DEVICE #2) AND BARD/DAVOL PHASIX ST(DEVICE #3). SHOULD ADDITIONAL INFORMATION BE PROVIDED, A SUPPLEMENTAL EMDR WILL BE SUBMITTED.

    Description of Event or Problem · 0

    ATTORNEY ALLEGES THAT THE PATIENT UNDERWENT SURGERY FOR IMPLANT OF BARD/DAVOL VENTRALEX HERNIA PATCH ON (B)(6) 2009, COMPOSIX L/P ON (B)(6) 2018 AND TWO PHASIX ST MESH ON (B)(6) 2018. AS REPORTED THE PATIENT IS MAKING A CLAIM FOR AN ADVERSE PATIENT OUTCOME AGAINST ALL DEVICES. ATTORNEY ALLEGES THAT THE PATIENT HAD SUBSEQUENT SURGICAL INTERVENTION DUE TO THE HERNIA MESH DEVICE. 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
    1816638 PHASIX ST MESH SURGICAL MESH OWT DAVOL INC., SUB. C.R. BARD, INC. NA NI

    Patients

    Seq Age Sex Outcome Treatment
    1 Female Required Intervention