BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VENTRALEX ST

    MDR report key: 7879538 · Received September 14, 2018

    Report

    Report Number
    1213643-2018-03128
    Event Type
    Injury
    Date Received
    September 14, 2018
    Date of Event
    June 18, 2017
    Report Date
    March 14, 2019
    Manufacturer
    DAVOL INC., SUB. C.R. BARD, INC.
    Product Code
    FTL
    UDI-DI
    00801741031472
    PMA / PMN Number
    K101928
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    RI, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    ADDENDUM TO THE PREVIOUS INFORMATION. THIS SUPPLEMENTA EMDR IS BEING SENT TO CORRECT THE EXPIRATION DATE OF THE DEVICE. WITH THE CURRENT INFORMATION AVAILABLE NO CONCLUSION CAN BE MADE. IF ADDITIONAL EVENT AND/OR EVALUATION INFORMATION IS OBTAINED, A FOLLOW UP EMDR WILL BE SUBMITTED.

    Description of Event or Problem · 0

    AS PREVIOUSLY REPORTED: THE FOLLOWING WAS ALLEGED BY THE PATIENT'S ATTORNEY: (B)(6) 2015 THE PATIENT UNDERWENT REPAIR OF INCISIONAL HERNIA. A BARD/DAVOL VENTRALEX ST MESH PATCH 1.7¿ IN DIAMETER, REFERENCE NUMBER 5950007, LOT NUMBER HUYD0314 WAS IMPLANTED IN THE PATIENT DURING THIS REPAIR. (B)(6) 2015 THE PATIENT UNDERWENT RECURRENT HERNIA REPAIR. AS ALLEGED DURING THE SURGERY THE SURGEON NOTED THAT THE MESH HAD ¿RETRACTED INTO THE HERNIA SAC AND WAS CRUMPLED, NO LONGER COVERING THE FASCIA AT ALL. THE SURGEON ALSO NOTED THAT HE ¿DID NOT MAKE AN ATTEMPT TO REMOVE THE MESH AS IT WAS DENSELY ADHERENT TO THE FASCIA SURROUNDING THE HERNIA AND IT WAS CRUMPLED INTO THE HERNIA SAC.¿ (B)(6) 2017: THE PATIENT UNDERWENT REMOVAL OF THE FAILED BARD/DAVOL VENTRALEX ST. AS REPORTED, THE SURGEON NOTED THAT ¿THE DECISION WAS MADE TO EXCISE THE BUNCHED-UP MESH UNDERNEATH THE UMBILICUS.¿ THE PATIENT CONTINUES TO EXPERIENCE COMPLICATIONS RELATED TO THE BARD/DAVOL VENTRALEX ST MESH. THE PATIENT WILL LIKELY REQUIRE ADDITIONAL SURGERIES TO REPAIR THE DAMAGE FROM THE PRODUCT. IT IS ALLEGED THAT THE BARD/DAVOL VENTRALEX ST MESH IS DEFECTIVE. THE PATIENT HAS BEEN INJURED AND HAS SUSTAINED SEVERE AND PERMANENT PAIN, SUFFERING, ANXIETY, DEPRESSION, DISABILITY, AND IMPAIRMENT.

    Additional Manufacturer Narrative · 1

    AT THIS TIME NO CONCLUSION CAN BE MADE AS TO WHAT EXTENT THE DEVICE MAY HAVE CAUSED OR CONTRIBUTED TO THE EVENTS AS ALLEGED BY THE PATIENT¿S ATTORNEY. THE INFORMATION PROVIDED ALLEGES REOCCURRENCE OF HERNIA, AND THAT THE MESH ¿RETRACTED INTO THE HERNIA SAC AND WAS CRUMPLED"; HOWEVER NO SAMPLE HAS BEEN RETURNED FOR EVALUATION AND NO MEDICAL RECORDS HAVE BEEN PROVIDED. RECURRENCE IS A KNOWN INHERENT RISK OF HERNIA REPAIR SURGERY AND IS IDENTIFIED IN THE ADVERSE REACTION SECTION OF THE INSTRUCTIONS-FOR-USE AS A POSSIBLE COMPLICATION. A REVIEW OF THE MANUFACTURING RECORDS WAS PERFORMED AND FOUND THAT THE LOT WAS MANUFACTURED TO SPECIFICATION. CURRENTLY INFORMATION IS LIMITED, SHOULD ADDITIONAL INFORMATION BE PROVIDED A SUPPLEMENTAL EMDR 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.

    Description of Event or Problem · 1

    THE FOLLOWING WAS ALLEGED BY THE PATIENT'S ATTORNEY: ON (B)(6) 2015: THE PATIENT UNDERWENT REPAIR OF INCISIONAL HERNIA. A BARD/DAVOL VENTRALEX ST MESH PATCH 1.7¿ IN DIAMETER, REFERENCE NUMBER 5950007, LOT NUMBER HUYD0314 WAS IMPLANTED IN THE PATIENT DURING THIS REPAIR. ON (B)(6) 2015: THE PATIENT UNDERWENT RECURRENT HERNIA REPAIR. AS ALLEGED DURING THE SURGERY THE SURGEON NOTED THAT THE MESH HAD ¿RETRACTED INTO THE HERNIA SAC AND WAS CRUMPLED, NO LONGER COVERING THE FASCIA AT ALL. THE SURGEON ALSO NOTED THAT HE ¿DID NOT MAKE AN ATTEMPT TO REMOVE THE MESH AS IT WAS DENSELY ADHERENT TO THE FASCIA SURROUNDING THE HERNIA AND IT WAS CRUMPLED INTO THE HERNIA SAC.¿ ON (B)(6) 2017: THE PATIENT UNDERWENT REMOVAL OF THE FAILED BARD/DAVOL VENTRALEX ST. AS REPORTED, THE SURGEON NOTED THAT ¿THE DECISION WAS MADE TO EXCISE THE BUNCHED-UP MESH UNDERNEATH THE UMBILICUS.¿ THE PATIENT CONTINUES TO EXPERIENCE COMPLICATIONS RELATED TO THE BARD/DAVOL VENTRALEX ST MESH. THE PATIENT WILL LIKELY REQUIRE ADDITIONAL SURGERIES TO REPAIR THE DAMAGE FROM THE PRODUCT. IT IS ALLEGED THAT THE BARD/DAVOL VENTRALEX ST MESH IS DEFECTIVE. THE PATIENT HAS BEEN INJURED AND HAS SUSTAINED SEVERE AND PERMANENT PAIN, SUFFERING, ANXIETY, DEPRESSION, DISABILITY, AND IMPAIRMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    719588 VENTRALEX ST SURGICAL MESH FTL DAVOL INC., SUB. C.R. BARD, INC. NA HUYD0314 00801741031472

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention| S