BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VENTRALIGHT ST W/ECHO

    MDR report key: 8139720 · Received December 6, 2018

    Report

    Report Number
    1213643-2018-04459
    Event Type
    Injury
    Date Received
    December 6, 2018
    Date of Event
    April 27, 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 AND A SAMPLE WAS NOT RETURNED FOR EVALUATION. BASED ON THE LIMITED INFORMATION PROVIDED AT THIS TIME, NO CONCLUSIONS CAN BE MADE. THIS EMDR REPRESENTS THE BARD/DAVOL VENTRALIGHT ST W/ECHO (DEVICE #1). THE PATIENT'S ATTORNEY DID NOT MAKE ANY ALLEGATIONS REGARDING THE IMPLANTED BARD/DAVOL VENTRALX ST W/ECHO DEVICE. 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: (B)(6) 2014: THE PATIENT UNDERWENT REPAIR OF AN INCISIONAL HERNIA. A BARD/DAVOL VENTRALIGHT ST W/ECHO MESH, REFERENCE NUMBER: 5955680, LOT NUMBER: HUYF1390 (DEVICE #1) WAS IMPLANTED IN PATIENT DURING THIS REPAIR. (B)(6) 2016: THE PATIENT UNDERWENT REPAIR OF A RECURRENT INCISIONAL HERNIA. A ROUND BARD/DAVOL VENTRALEX ST W/ECHO MESH, REFERENCE NUMBER: 5950008, LOT NUMBER: HUAS0521 WAS IMPLANTED IN PATIENT DURING THIS REPAIR. (B)(6) 2017: THE PATIENT UNDERWENT A PROCEDURE. UPON ENTERING THE PATIENT ABDOMEN, THE DOCTOR NOTED AN EXTENSIVE AMOUNT OF ADHESIONS AT THE SITE OF THE PREVIOUS MESH PLACEMENT, WHICH ADHESIONS WERE PAINSTAKINGLY LYSED. ADDITIONALLY, THE ADHESIONS WERE LYSED FROM THE HERNIA DEFECT PROXIMAL TO THE PREVIOUS LOWER MESH AND THE DEFECT WAS REPAIRED. THE ST BARD MESH (VENTRALIGHT ST W/ECHO) WAS REMOVED. PRIOR TO AND AFTER THESE PROCEDURES, PATIENT SUFFERED SEVERE AND DEBILITATING PAIN. AS ALLEGED, THE PATIENT WAS CAUSED TO SUFFER SEVERE PERSONAL INJURIES, PAIN AND SUFFERING, AND OTHER DAMAGES. AS REPORTED, THE PATIENT'S ATTORNEY IS ONLY MAKING A CLAIM AGAINST THE BARD/DAVOL VENTRALIGHT ST W/ECHO MESH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    978875 VENTRALIGHT ST W/ECHO SURGICAL MESH FTL DAVOL INC., SUB. C.R. BARD, INC. NA HUYF1390 00801741031755

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention| S