BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VENTRALIGHT ST MESH

    MDR report key: 25124103 · Received May 8, 2026

    Report

    Report Number
    1213643-2026-00604
    Event Type
    Malfunction
    Date Received
    May 8, 2026
    Date of Event
    April 16, 2026
    Report Date
    April 21, 2026
    Manufacturer
    DAVOL INC., SUB. C.R. BARD, INC. -1213643
    Product Code
    FTL
    UDI-DI
    00801741031632
    PMA / PMN Number
    K101851
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    AS REPORTED, DURING A LAPAROSCOPIC VENTRAL HERNIA REPAIR PROCEDURE, THE HYDROGEL (ST) BARRIER OF VENTRALIGHT ST MESH WAS PEELING OFF AFTER INSERTING THROUGH THE 8MM ROBOT TROCAR. THE SAMPLE WAS NOT AVAILABLE FOR EVALUATION. HOWEVER, REPORTEDLY, THE SIZE OF TROCAR USED WAS AN 8MM. PER IFU, THE RECOMMENDED TROCAR SIZE FOR THE VENTRALIGHT ST MESH (5954600) IS 10MM. THE SEPARATION OF THE HYDROGEL COATING IS LIKELY THE RESULT OF USING A SMALLER SIZE TROCAR THEN RECOMMENDED. THE IFU STATES: "A MINIMUM SIZED TROCAR IS RECOMMENDED FOR THE LAPAROSCOPIC DELIVERY OF VENTRALIGHT ST MESH. INSERT THE MESH THROUGH THE TROCAR USING A RIGID INSTRUMENT, SUCH AS NON-SERRATED 5 MM FORCEPS; DO NOT OVER FORCE THE MESH THROUGH THE TROCAR. IF VENTRALIGHT ST MESH IS HYDRATED LONGER THAN 3 SECONDS AND/OR DOES NOT EASILY DEPLOY THROUGH THE TROCAR, REPLACE THE TROCAR AND RETRY WITH THE NEXT AVAILABLE, LARGER SIZED TROCAR." A REVIEW OF THE MANUFACTURING RECORDS FOR THE REPORTED LOT NUMBER CONFIRMED THAT THE LOT WAS MANUFACTURED IN ACCORDANCE WITH APPLICABLE SPECIFICATIONS. TO DATE, THIS IS THE ONLY REPORTED COMPLAINT FOR THIS LOT OF (B)(4) RELEASED FOR DISTRIBUTION. 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.

    Description of Event or Problem · 0

    AS REPORTED, DURING A LAPAROSCOPIC VENTRAL HERNIA REPAIR PROCEDURE, THE HYDROGEL (ST) BARRIER COATING CAME OFF ENTIRELY FROM THE VENTRALIGHT ST MESH. REPORTEDLY, THE MESH WAS HYDRATED IN SALINE (QUICK DIP 1-3 SECONDS) AND WAS ROLLED IMMEDIATELY WITH ST COATING INSIDE. THE HYDROGEL (ST) BARRIER WAS PEELING OFF AFTER INSERTING THROUGH THE 8MM ROBOT TROCAR. THE MESH WAS REMOVED, AND ANOTHER MESH WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO PATIENT HARM OR INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    4666 VENTRALIGHT ST MESH SURGICAL MESH FTL DAVOL INC., SUB. C.R. BARD, INC. -1213643 NA HUJU0951 00801741031632

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other