BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MESH

    MDR report key: 1270784 · Received December 19, 2008

    Report

    Report Number
    1213643-2008-00560
    Event Type
    Injury
    Date Received
    December 19, 2008
    Date of Event
    August 24, 2006
    Report Date
    November 24, 2008
    Manufacturer
    DAVOL INC., SUB. C.R. BARD, INC.
    Product Code
    FTL
    PMA / PMN Number
    K971745
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Additional Manufacturer Narrative · 1

    CURRENTLY, IT IS UNK 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 INFO BECOMES AVAILABLE. INFO RELATED TO THE PERFIX PLUG IMPLANTED ON 05/04/2006, WAS REPORTED ON MDR 1213643-2008-00462. INFO RELATED TO THE VENTRALEX MESH, LOT NUMBER 43AQD504, IMPLANTED IN 2006, WAS REPORTED ON MDR 1213643-2008-00463. SEE MDR 1213643-2008-00558 FOR INFO RELATED THE VENTRALEX MESH, LOT NUMBER 43BQD509, IMPLANTED ON THE SAME DAY. SEE MDR 1213643-2008-00559 FOR INFO RELATED THE VENTRALEX MESH, LOT NUMBER 43EQD856, IMPLANTED APPROX FOUR MONTHS LATER.

    Description of Event or Problem · 1

    INFO A COMBINATION OF ATTORNEY REPORTED INFO AND INFO CONTAINED IN PROVIDED MEDICAL RECORDS: 2006- THE PT UNDERWENT SURGERY WITH IMPLANT OF THREE MESH PATCHES: ONE PERFIX PLUG 0112960 AND TWO VENTRALEX: 0010301, LOT NUMBER 43AQD504 & 0010301 LOT NUMBER, 43BQD509. FOUR MONTHS LATER, THE PERFIX PLUG WAS SURGICALLY REMOVED. DURING THE SAME DAY SURGERY, ONE OF THE VENTRALEX MESH WAS FOUND TO BE ADHERENT TO THE BOWEL WITH INJURY TO HER RIGHT INGUINAL NERVE. ON THE SAME DAY - TWO ADDITIONAL PATCHES WERE PLACED IN THE PT: ONE VENTRALEX, LOT NUMBER 43EQD856, AND ONE COMPOSIX MESH LOT NUMBER 43COD192. ON THE SAME DAY - THE PATIENT WAS HOSPITALIZED AND HAD TWO INFECTIONS AT THE RIGHT GROIN AREA. THE PATIENT REMAINED HOSPITALIZED FOR A WEEK. THE PATIENT REPORTED THAT THE PAIN HAD IMPROVED SINCE THE INJECTION UNTIL HER FOLLOWING MONTH'S DOCTOR'S VISIT. TWO DAYS LATER - THE PT IS PRESENTED TO HER PHYSICIAN WITH REPORTS OF PAIN, NUMBNESS AND BURNING SENSATION IN FRONT OF HER THIGH, BELOW THE GROIN AREA, ALL THE WAY DOWN TO HER KNEE. ON THE NEXT DAY - THE PATIENT WAS DIAGNOSED WITH ILIOINGUINAL NERVE ENTRAPMENT SYNDROME ON THE RIGHT. THE PATIENT UNDERWENT AN ILIOINGUINAL NERVE BLOCK ON THE RIGHT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MESH FTL DAVOL INC., SUB. C.R. BARD, INC. NA 43COD192

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention