BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MESH -VENTRALEX

    MDR report key: 6740128 · Received July 25, 2017

    Report

    Report Number
    1213643-2017-00430
    Event Type
    Malfunction
    Date Received
    July 25, 2017
    Report Date
    July 25, 2017
    Manufacturer
    DAVOL INC., SUB. C.R. BARD, INC.
    Product Code
    FTL
    UDI-DI
    00801741000355
    PMA / PMN Number
    K132441
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THIS INITIAL MDR IS BEING SUBMITTED AS A RESULT OF A RETROSPECTIVE REVIEW OF DAVOL¿S MDR DECISIONS AND THE INITIAL DECISION NOT TO REPORT THE EVENT IS BEING REVISED TO REFLECT UPDATED COMPANY PROCEDURES. VISUAL EXAMINATION FINDS THE DEVICE IN A DAMAGED CONDITION. THE PDO RING WITHIN THE MESH POCKET IS PARTIALLY DETACHED AND MESH IS DAMAGED (TORN). POSITIONING STRAP HAS BEEN REMOVED BY USER BASED ON THE SAMPLE EVALUATION THIS COMPLAINT IS CONFIRMED. THE NOTED DAMAGE IS CONSISTENT WITH A HANDLING RELATED ISSUE. IT APPEARS THAT WHEN ATTEMPTING TO SUTURE THE MESH AFTER POSITIONING IT IN PLACE, THE DEVICE WAS INADVERTENTLY DAMAGED BY THE USER. A REVIEW OF THE MANUFACTURING RECORDS WAS PERFORMED AND FOUND THAT THE LOT WAS MANUFACTURED TO SPECIFICATION. THE INFORMATION PROVIDED BY BARD 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 BARD.

    Description of Event or Problem · 1

    ALLEGED "CUSTOMER REPORTS THE VENTRALEX MESH ( 0010301 ; HUZG0681 )" SHREDDED INTO SEVERAL PIECES "WHEN THE DOCTOR BEGAN SUTURING THE MESH DURING AN UMBILICAL REPAIR. THE SURGEON REMOVED THE PIECES AND SUTURED IN ANOTHER VENTRALEX PATCH WITHOUT A PROBLEM." THE UMBILICAL CASE WAS BEING PERFORMED IN AN OPEN FASHION WITH SUTURES ONLY. SURGEON WAS NOT USING ADDITIONAL FORCE OR UNUSUAL TECHNIQUE. NO PATIENT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    521085 MESH -VENTRALEX SURGICAL MESH FTL DAVOL INC., SUB. C.R. BARD, INC. NA HUZG0681 00801741000355

    Patients

    Seq Age Sex Outcome Treatment
    1