BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BARD "COMPOSIX" E/X MESH, ELLIPSE 8"X10" (20.3 CM X 25 CM)

    MDR report key: 4739484 · Received April 25, 2015

    Report

    Report Number
    MW5042373
    Event Type
    Injury
    Date Received
    April 25, 2015
    Date of Event
    May 28, 2013
    Report Date
    April 24, 2015
    Manufacturer
    BARD
    Product Code
    FTL
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    NY, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    ON (B)(6) 2013, I UNDERWENT EXPLORATORY LAPAROTOMY AND COMPLEX HERNIA REPAIR WITH MESH. MY HERNIA MEASURED 15 X 25CM. A 20.3 X 25.4 CM BARD COMPOSIX E/X MESH WAS PLACED. I HAVE HAD COMPLICATIONS AND CONSTANT ABDOMINAL PAIN EVER SINCE THE HERNIA REPAIR SURGERY. I AM CONSTANTLY CONSTIPATED DESPITE ALL THE MEDS I AM TAKING FOR IT) AND I BLEED WITH EACH BOWEL MOVEMENT. I'VE HAD AN ANAL FISSURE FOR A WHILE AND MEDS HAVE NOT HELPED IT. I ALSO HAVE EXCRUCIATING PAIN WHEN I DO HAVE A BOWEL MOVEMENT. I AM NOW HAVING A SIGMOIDOSCOPY WITH BOTOX INJECTIONS AT (B)(6) HOSPITAL ON (B)(6) 2015. MY ABDOMINAL PAIN RANGES FROM: SHARP STABBING PAIN, BURNING, PINCHING, PULLING, FEELING LIKE MY INSIDES ARE RAW, AND THE FEELING OF BROKEN GLASS OR A BUNCH OF NEEDLE PIERCING ME. I AM IN CONSTANT PAIN AND FEEL EXHAUSTED ALL THE TIME. I HAVE BEEN SEEING A PAIN MANAGEMENT DOCTOR AND I AM ON PAIN MEDS THAT THEY ONLY HELP A LITTLE. I AM THOUGHT TO HAVE NERVE ENTRAPMENT BUT I HAVEN'T HAD AN ABDOMINAL MRI OR CT SCAN IN ALMOST ONE YEAR. MY REPAIR SURGERY SEEMED TO HAVE DONE MORE DAMAGE THAN GOOD. THIS IS A MISERABLE QUALITY OF LIFE. I DON'T KNOW WHAT I AM GOING TO DO. THERE IS DEFINITELY SOMETHING VERY WRONG.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    274798 BARD "COMPOSIX" E/X MESH, ELLIPSE 8"X10" (20.3 CM X 25 CM) BARD "COMPOSIX" E/X MESH FTL BARD 0123810 HUT10954

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR Required Intervention| S DULOXETINE HCL DR 30 MG CAP 1 X DAY MORNING| ANUSOL HC 2.5% CREAM (HYDROCORTISONE RECTAL),| GABAPENTIN 400 MG 3X DAY| POLYETHYLENE GLYCOL 3350 NF 1 OR 2 X DAY| 81 MG ASPIRIN 1 X DAY| 2-3 TIMES A DAY| NITRO-BID 2% OINT (NITROGLYCERIN) BID & BEFORE,| DULOXETINE HCL DR 60 MG CAP 1 X DAY BEDTIME| MECLIZINE 25 MG 3 X DAY AS NEEDED| HYDROCHLROTHIAZIDE 2.5 MG 1X DAY| BENEFIBER 2 X A DAY| ONDANSETRON HCL 4MG (ZOFRAN) 1 EVERY 6 HRS AS NEED| EXTRA STRENTH TYLENOL 1000MG AS NEEDED| MELOXICAN 15MG 1X AT BEDTIME WHEN NEEDED| BOWEL MOVEMENT| DOCUSATE SODIUM 100MG 3 X DAY| VITAMIN C 1 X DAY