BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VENTRALEX MESH

    MDR report key: 1202801 · Received October 17, 2008

    Report

    Report Number
    1213643-2008-00463
    Event Type
    Injury
    Date Received
    October 17, 2008
    Date of Event
    August 24, 2006
    Report Date
    September 19, 2008
    Manufacturer
    DAVOL INC., SUB. C.R. BARD, INC.
    Product Code
    FTL
    PMA / PMN Number
    K021736
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CURRENTLY, IT IS UNKNOWN WHETHER OR NOT THE DEVICE MAY HAVE CAUSED OR CONTRIBUTED TO THE EVENT AS NO PRODUCT HAS BEEN RETURNED. NO CONCLUSION CAN BE DRAWN AT THIS TIME. WE WILL SUBMIT A FOLLOW UP REPORT WHEN/IF PRODUCT IS RETURNED FOR EVALUATION OR ADDITIONAL INFORMATION BECOMES AVAILABLE. SEE MDR 1213643-2008-00462 FOR INFORMATION RELATED TO THE PERFIX PATCH EXPLANTED DURING THE 2006 SURGERY.

    Description of Event or Problem · 1

    ATTORNEY REPORTED: 2006- PATIENT WAS IMPLANTED WITH 3 BARD MESHES (1 BARD MESH PERFIX PLUG, PRODUCT CODE 0112960 AND 2 BARD VENTRALEX HERNIA PATCHES, PRODUCT CODE 0010301). THREE MONTHS LATER, PATIENT UNDERWENT A FURTHER SURGERY AS A RESULT OF A FAILURE OR PARTIAL FAILURE OF THE 2006, PROCEDURE. DURING THIS PROCEDURE, THE BARD MESH PERFIX PLUG WAS SURGICALLY REMOVED. DURING THIS SURGERY, ONE OF THE VENTRALEX HERNIA PATCHES WAS FOUND TO BE ADHERENT TO THE BOWEL. DURING THIS PROCEDURE, TWO ADDITIONAL PATCHES WERE PLACED IN THE PATIENT (BARD VENTRALEX HERNIA PATCH, PRODUCT CODE 0010301 AND A BARD COMPOSIX MESH, PRODUCT CODE 0113480). AS A RESULT OF THE 2008, PATIENT SUFFERED AN INJURY TO HER RIGHT INGUINAL NERVE AND IS AT RISK OF FURTHER COMPLICATIONS AND INJURIES IN THE FUTURE AS A RESULT OF THE PATCHES REMAINING IN HER. PER MEDICAL RECORD INFORMATION IN 2006, PATIENT UNDERWENT INIOINGUINAL NERVE BLOCK ON THE RIGHT. PLAN INCLUDED NUERONTIN 300 MG, P.Q.M. X 3 DAYS THEN TITRATE UP AS NEEDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VENTRALEX MESH FTL DAVOL INC., SUB. C.R. BARD, INC. NA NI

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR Required Intervention