BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PHASIX ST MESH

    MDR report key: 14401396 · Received May 13, 2022

    Report

    Report Number
    1213643-2022-00227
    Event Type
    Injury
    Date Received
    May 13, 2022
    Date of Event
    April 22, 2022
    Report Date
    April 26, 2022
    Manufacturer
    DAVOL INC., SUB. C.R. BARD, INC. -1213643
    Product Code
    OWT
    PMA / PMN Number
    K143380
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    AS REPORTED, POST-IMPLANT OF PHASIX ST MESH THE PATIENT DEVELOPED FISTULA AND THE SURGEON IS PLANNING FOR ADDITIONAL SURGERY. BASED ON THE AVAILABLE INFORMATION, NO CONCLUSIONS CAN BE MADE. NO LOT NUMBER HAS BEEN PROVIDED; THEREFORE, A REVIEW OF THE MANUFACTURING RECORDS IS NOT POSSIBLE. FISTULA FORMATION IS A KNOWN INHERENT RISK OF SURGERY AND IS LIST IN THE ADVERSE REACTIONS SECTION OF THE INSTRUCTIONS-FOR-USE (IFU), SUPPLIED WITH THE DEVICE AS A KNOWN POSSIBLE COMPLICATION. NOTE, THE DATE OF EVENT IS PROVIDED AS A BEST ESTIMATE (22-APR-2022) BASED ON THE DATE OF AWARENESS. REMAINS IMPLANTED.

    Description of Event or Problem · 0

    AS REPORTED, DURING AN UNKNOWN PROCEDURE ON (B)(6) 2021 THE PATIENT UNDERWENT AN ABDOMINAL CLOSURE OVER SEVERAL SMALL BOWEL ANASTOMOSES, WHERE A BARD/DAVOL PHASIX ST MESH WAS IMPLANTED. AS REPORTED, POST-IMPLANT OF THE MESH, THE PATIENT DEVELOPED AN ENTEROCUTANEOUS FISTULA WHICH RESULTED IN SLOWER NEW SKIN GROWTH. AS REPORTED, THE SURGEON IS PLANNING FOR AN ADDITIONAL SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1039128 PHASIX ST MESH SURGICAL MESH OWT DAVOL INC., SUB. C.R. BARD, INC. -1213643 NA NI

    Patients

    Seq Age Sex Outcome Treatment
    1 Female Required Intervention