BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VENTRALIGHT ST W/ECHO

    MDR report key: 7879540 · Received September 14, 2018

    Report

    Report Number
    1213643-2018-03131
    Event Type
    Injury
    Date Received
    September 14, 2018
    Date of Event
    August 29, 2015
    Report Date
    September 14, 2018
    Manufacturer
    DAVOL INC., SUB. C.R. BARD, INC.
    Product Code
    FTL
    UDI-DI
    00801741031755
    PMA / PMN Number
    K122436
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    RI, US
    Reporter Occupation
    003

    Narratives

    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 REPORTED EVENT. THE INFORMATION PROVIDED ALLEGES THAT THE PATIENT UNDERWENT AN ADDITIONAL "EXPLORATORY SURGERY" FOR A SMALL BOWEL OBSTRUCTION WITH LYSIS OF ADHESIONS. ADHESIONS ARE A KNOWN INHERENT RISK OF SURGERY AND IS LISTED IN THE INSTRUCTIONS-FOR-USE A POSSIBLE COMPLICATION. INFORMATION IS LIMITED AT THIS TIME, AND NO MEDICAL RECORDS HAVE BEEN PROVIDED. A REVIEW OF THE MANUFACTURING RECORDS WAS CONDUCTED. PRODUCT WAS MANUFACTURED TO SPECIFICATION WITH NO ANOMALIES. 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 VENTRAL HERNIA REPAIR. A BARD/DAVOL 6 X 8¿ VENTRALIGHT ST [W/ECHO] MESH, CAT NO. 5955680 LOT NO. HUZC1574 WAS IMPLANTED IN PATIENT DURING THIS REPAIR. ON (B)(6) 2015: THE PATIENT PRESENTED TO THE HOSPITAL DUE TO A SMALL-BOWEL OBSTRUCTION AND UNDERWENT AN EXPLORATORY LAPAROTOMY WITH EXTENSIVE LYSIS OF ADHESIONS. AS ALLEGED, UPON ENTERING THE PATIENT'S ABDOMEN, THE SURGEON NOTED ¿DENSE ADHESIONS OF THE SMALL BOWEL¿ AND HAD TO ¿SEPARATE THE UNDERLYING OMENTUM AND BOWEL STRUCTURES FROM THE MESH.¿ AS REPORTED, THE SURGEON ALSO NOTED ¿A FAIR AMOUNT OF PERITONEAL FLUID AND ASCITES, IT WAS MOSTLY CLEAR IN NATURE.¿ THE BARD/DAVOL VENTRALIGHT ST [W/ECHO] MESH IS DEFECTIVE. THE BARD/DAVOL VENTRALIGHT ST [W/ECHO] MESH IMPLANTED IN THE PATIENT FAILED TO REASONABLY PERFORM AS INTENDED. THE PATIENT HAS BEEN INJURED, SUSTAINED SEVERE AND PERMANENT PAIN, SUFFERING, ANXIETY, DEPRESSION AND IMPAIRMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    719592 VENTRALIGHT ST W/ECHO SURGICAL MESH FTL DAVOL INC., SUB. C.R. BARD, INC. NA HUZC1574 00801741031755

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention| S