BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PHASIX ST MESH

    MDR report key: 20469566 · Received October 17, 2024

    Report

    Report Number
    1213643-2024-094755
    Event Type
    Injury
    Date Received
    October 17, 2024
    Report Date
    October 17, 2024
    Manufacturer
    DAVOL INC., SUB. C.R. BARD, INC.
    Product Code
    OWT
    UDI-DI
    00801741095351
    PMA / PMN Number
    K143380
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PR, 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. SHOULD ADDITIONAL INFORMATION BE PROVIDED, A SUPPLEMENTAL EMDR WILL BE SUBMITTED. NOTE: SECTION A THROUGH F - THE INFORMATION PROVIDED BY BD REPRESENTS ALL OF THE KNOWN INFORMATION AT THIS TIME. DESPITE GOOD FAITH EFFORTS TO OBTAIN ADDITIONAL INFORMATION, THE COMPLAINANT / REPORTER WAS UNABLE OR UNWILLING TO PROVIDE ANY FURTHER PATIENT, PRODUCT, OR PROCEDURAL DETAILS TO BD.NOT RETURNED.

    Description of Event or Problem · 0

    ATTORNEY ALLEGES THAT THE PATIENT UNDERWENT SURGERY FOR IMPLANT OF AN UNSPECIFIED BARD/DAVOL PHASIX ST (CAT# 1201520) ON (B)(6) 2022. AS REPORTED, THE PATIENT IS MAKING A CLAIM FOR AN ADVERSE PATIENT OUTCOME AGAINST PHASIX ST (CAT# 1201520). 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
    1034817 PHASIX ST MESH SURGICAL MESH OWT DAVOL INC., SUB. C.R. BARD, INC. NA NI 00801741095351

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female Required Intervention