BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VENTRALIGHT ST

    MDR report key: 6701745 · Received July 11, 2017

    Report

    Report Number
    1213643-2017-00396
    Event Type
    Injury
    Date Received
    July 11, 2017
    Date of Event
    February 15, 2013
    Report Date
    July 11, 2017
    Manufacturer
    DAVOL INC., SUB. C.R. BARD, INC.
    Product Code
    FTL
    PMA / PMN Number
    K101851
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    WITHOUT A LOT NUMBER A REVIEW OF THE MANUFACTURING RECORDS COULD NOT BE CONDUCTED. HERNIA RECURRENCE IS LISTED AS A KNOWN POSSIBLE ADVERSE REACTION IN THE INSTRUCTIONS-FOR-USE. THE PROVIDED INFORMATION INDICATES THAT THE VENTRALIGHT ST WAS EXPLANTED IN (B)(6) 2013, HOWEVER THE EVENT DESCRIPTION ALLEGES THE MESH HAS "NOW FAILED," THEREFORE THE PATIENT'S CLINICAL COURSE IS UNCLEAR. THE MAUDE EVENT REPORT DID NOT INCLUDE CONTACT INFORMATION FOR THE COMPLAINANT; AS SUCH NO ATTEMPTS CAN BE MADE TO REQUEST ADDITIONAL INFORMATION. BASED ON THE INFORMATION PROVIDED AT THIS TIME, NO CONCLUSIONS CAN BE MADE. SHOULD ADDITIONAL INFORMATION BE PROVIDED, A SUPPLEMENT MDR WILL BE SUBMITTED. 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. NOT RETURNED TO MANUFACTURER.

    Description of Event or Problem · 1

    THE FOLLOWING WAS REPORTED VIA MAUDE EVENT REPORT (MW 5070210): "IMPLANTED BARD UMBILICAL HERNIA MESH (VENTRALEX) FAILED AND HAD TO BE REMOVED. VENTRALIGHT ST MESH WAS IMPLANTED AS A REPLACEMENT. VENTRALIGHT ST HAS NOW FAILED AND NEED ADDITIONAL SURGERY FOR REPAIR."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    481354 VENTRALIGHT ST SURGICAL MESH FTL DAVOL INC., SUB. C.R. BARD, INC. NI

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R| S