BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DAVOL INC. SUB C.R. BARD, INC. 3D MAX MESH

    MDR report key: 3727794 · Received March 28, 2014

    Report

    Report Number
    MW5035467
    Event Type
    Injury
    Date Received
    March 28, 2014
    Date of Event
    May 18, 2001
    Report Date
    March 22, 2014
    Manufacturer
    DAVOL INC. SUB. C.R. BARD, INC.
    Product Code
    FTL
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    SC, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    DAY AFTER MY SURGERY, COMPLICATIONS STARTED WORSE THAN WHEN I WENT IN. COMPLICATIONS OF : SEVERE PAIN TO LEFT AND RIGHT ABDOMEN, PAIN IN MY GROIN AREA, SICK TO THE STOMACH, PROBLEMS WHEN HAVING SEX. IT IS CAUSING BIG PROBLEMS BETWEEN MY WIFE AND I DURING SEX. I HAVE A DULL PAIN AND BURNING IN MY GROIN AREA ALL THE TIME. PAIN SHOOTING IN MY LEFT AND RIGHT SIDE, LIKE SOMEONE IS STABBING ME WITH A KNIFE. PAIN SHOOTING DOWN MY LEGS, AND I ALWAYS, ALWAYS STAY SICK TO MY STOMACH FROM THESE PATCHES. (B)(6) 2012, THAT'S WHEN THE BARD 3-D MAX MESH PATCHES STARTED TO CUT INTO MY INTESTINE AND CAUSE ME TO INTERNAL BLEED INSIDE AND COME OUT OF MY RECTUM DURING BOWEL MOVEMENTS. THE BLOOD BLEEDS HEAVY AT TIMES. THIS IS STILL HAPPENING TO ME TODAY. THIS MESH (BARD 3-7 MAX) HAS NOT CAUSE ME TO BLEED INSIDE AND OUT OF MY RECTUM. ON SATURDAY (B)(6) 2012, FOUND BLOOD IN STOOL AT OR AROUND 6:30 - 7:00PM. SUN (B)(6) 2012. FOUND BLOOD IN STOOL AT 11:35 AM THIS MORNING. SAME AMOUNT OF BLOOD IN MY STOOL AS OF (B)(6) 2012: SAW BLOOD WHEN I WIPED MYSELF AT 5:10PM, VERY LITTLE ON TISSUE. (NO BLOOD IN STOOL ONLY ON TISSUE). WED (B)(6) 2012: FOUND BLOOD IN MY RECTUM AT 10:12 AM THIS MORNING, GOOD BIT, BUT NOT LARGE AMOUNT. WEDNESDAY (B)(6) 2012: FOUND TRACE'S OF BLOOD IN STOOL AND TISSUE AT 3:30PM THIS EVENING, ONLY SMALL TRACES. THURSDAY (B)(6) 2012: FOUND BLOOD IN STOOL AND WHEN I WIPED AT 9:02PM TONIGHT, FOUND A GOOD BIT. WEDNESDAY (B)(6) 2013: FOUND BLOOD IN STOOL AND WHEN I WIPED AT 12:47 PM TODAY, FOUND A GOOD BIT IN STOOL. THURSDAY (B)(6) 2013: FOUND BLOOD IN STOOL AND WHEN I WIPED AT 5:44 PM TODAY, IT WAS A GOOD BIT IN STOOL. DURING THE TIME OF BLEEDING, I WAS AND AM TAKING BC POWDERS, SINUS PULLS FROM ALKA-SELTZER PLUS, MY MEDICATION AND ACID REFLUX PILLS, OVER THE COUNTER FROM (B)(6).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    184907 DAVOL INC. SUB C.R. BARD, INC. 3D MAX MESH DAVOL INC. SUB C.R. BARD, INC. 3D MAX MESH FTL DAVOL INC. SUB. C.R. BARD, INC. RIGHT MEDIUM: 81CLR198 RIGHT - 0115320
    185037 DAVOL INC., SUB. C.R. BARD, INC. 3D MAX MESH DAVOL INC., SUB. C.R. BARD, INC. 3D MAX MESH FTL DAVOL INC. SUB. C.R. BARD, INC. LEFT LARGE: 81CLA214 LEFT - 0115311

    Patients

    Seq Age Sex Outcome Treatment
    1 35 YR Hospitalization| L| O| R| S 0.083 PERCENT 2.5MG| ALBUTEROL SULFATE INHALATION SOLUTION,| PAIN PILLS FOR PAIN COMING FROM MESH PATCHES| NEBULIZER TO OPEN AIRWAY