BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VENTRALIGHT ST W/ECHO

    MDR report key: 8139599 · Received December 6, 2018

    Report

    Report Number
    1213643-2018-04457
    Event Type
    Injury
    Date Received
    December 6, 2018
    Date of Event
    December 4, 2017
    Report Date
    December 6, 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

    THE CAUSE OF THE PATIENT'S POST-OP COMPLICATIONS CANNOT BE DETERMINED AT THIS TIME. RECURRENCE AND ADHESIONS ARE KNOWN INHERENT RISKS OF SURGERY AND ARE LISTED IN THE INSTRUCTIONS-FOR-USE AS POSSIBLE COMPLICATIONS. NO MEDICAL RECORDS HAVE BEEN PROVIDED. BASED ON THE LIMITED INFORMATION PROVIDED AT THIS TIME, NO CONCLUSIONS CAN BE MADE. SHOULD ADDITIONAL INFORMATION BE PROVIDED A SUPPLEMENTAL EMDR WILL BE SUBMITTED. NOTE: NO SAMPLE RETURNED.

    Description of Event or Problem · 1

    THE FOLLOWING WAS ALLEGED BY THE PATIENT'S ATTORNEY: ON (B)(6) 2014: THE PATIENT UNDERWENT REPAIR OF AN INCISIONAL HERNIA. A 15.2CM X 20.3 CM VENTRALIGHT ST W/ECHO BARD MESH, REFERENCE NUMBER 5955680, LOT NUMBER HUYG0043 WAS IMPLANTED IN PATIENT DURING THIS REPAIR. ON (B)(6) 2016: THE PATIENT UNDERWENT A PROCEDURE. UPON ENTERING THE PATIENT'S ABDOMEN, THE DOCTOR NOTED A LARGE AMOUNT OF DENSE ADHESIONS OF THE SMALL BOWEL, OMENTUM AND TRANSVERSE COLON TO THE MESH. THE DOCTOR LYSED ALL OF THE ADHESIONS FROM THE SMALL BOWEL, OMENTUM AND TRANSVERSE COLON TO THE MESH. THE DOCTOR ALSO NOTED THAT THE MESH HAD DETACHED ON THE RIGHT SIDE, WHICH HE REATTACHED WITH TACKS. ON (B)(6) 2017: THE PATIENT UNDERWENT A PROCEDURE. UPON ENTERING THE PATIENT'S ABDOMEN, THE DOCTOR NOTED DENSE ADHESIONS OF THE SMALL BOWEL, OMENTUM AND TRANSVERSE COLON TO THE MESH. THE DOCTOR LYSED ALL OF THE ADHESIONS FROM THE SMALL BOWEL, OMENTUM AND TRANSVERSE COLON TO THE MESH. IT WAS ALSO NOTED THAT THERE WAS A RECURRENCE IN THE LEFT LATERAL ASPECT OF THE MESH, WHICH HE REPAIRED. ATTORNEY ALLEGES GENERAL ALLEGATIONS FOR PAST, PRESENT, AND FUTURE DAMAGES, INCLUDING BUT NOT LIMITED TO, PAIN AND SUFFERING FOR SEVERE AND PERMANENT PERSONAL INJURIES SUSTAINED BY PATIENT, PERMANENT IMPAIRMENT, MENTAL PAIN AND SUFFERING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    979163 VENTRALIGHT ST W/ECHO SURGICAL MESH FTL DAVOL INC., SUB. C.R. BARD, INC. NA HUYG0043 00801741031755

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention| S