BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PHASIX ST MESH

    MDR report key: 16861806 · Received May 3, 2023

    Report

    Report Number
    1213643-2023-00170
    Event Type
    Malfunction
    Date Received
    May 3, 2023
    Date of Event
    April 12, 2023
    Report Date
    April 19, 2023
    Manufacturer
    DAVOL INC., SUB. C.R. BARD, INC. -1213643
    Product Code
    OWT
    UDI-DI
    00801741095337
    PMA / PMN Number
    K143380
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    PHOTOS WERE PROVIDED FOR REVIEW AND CONFIRM SEPARATION OF THE HYDRO-GEL BARRIER. AS REPORTED THE PHASIX ST MESH WAS INTRODUCED INTO THE BODY CAVITY WITHOUT FIRST HYDRATING THE PRODUCT. BASED ON THE PHOTO EVALUATION AND INVESTIGATION PERFORMED, THE ROOT CAUSE OF THE SEPARATION IS THE RESULT OF NOT HYDRATING THE MESH PRIOR TO USE. PER THE INSTRUCTIONS-FOR-USE (IFU), SUPPLIED WITH THE DEVICE, THE "PHASIX ST MESH SHOULD BE HYDRATED IN SALINE FOR NO MORE THAN 1-3 SECONDS JUST PRIOR TO LAPAROSCOPIC PLACEMENT. TO PROTECT THE RESORBABLE COATING DURING LAPAROSCOPIC MESH INSERTION, INSERT THE PROSTHESIS THROUGH THE TROCAR USING A RIGID INSTRUMENT, SUCH AS NON-SERRATED, 5 MM FORCEPS; DO NOT FORCE THE PROSTHESIS THROUGH TROCAR. IF PHASIX ST MESH IS HYDRATED LONGER THAN 3 SECONDS AND/OR DOES NOT EASILY DEPLOY DOWN THE TROCAR, REPLACE TROCAR AND RETRY WITH THE NEXT AVAILABLE LARGER SIZED TROCAR. NOTE, THE TROCAR SIZE USED IN THIS PROCEDURE WAS NOT PROVIDED, HOWEVER THE MINIMUM TROCAR SIZE PER THE IFU FOR PRODUCT CODE USED (1200710) IS 12MM. REVIEW OF MANUFACTURING RECORDS CONFIRMS PRODUCT WAS MANUFACTURED TO SPECIFICATION. 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. H3: NOT RETURNED.

    Description of Event or Problem · 0

    AS REPORTED, A PHASIX ST MESH WAS PLACED INTO THE PATIENT¿S BODY WITHOUT HYDRATION. IT WAS REPORTED THAT UPON CONTACT WITH THE TISSUE, THE MESH BENDS COMPLETELY AND FIXATION BECOMES IMPOSSIBLE. THERE WAS NO REPORTED PATIENT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    715051 PHASIX ST MESH SURGICAL MESH OWT DAVOL INC., SUB. C.R. BARD, INC. -1213643 NA HUGV1577 00801741095337

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other