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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BARD / DAVOL INC., SUB C.R BARD, INC. HERNIA MESH MESH, SURGICAL, POLYMERIC

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BARD / DAVOL INC., SUB C.R BARD, INC. HERNIA MESH MESH, SURGICAL, POLYMERIC Back to Search Results
Model Number IN MY MEDICAL RECORDS
Device Problem Nonstandard Device (1420)
Patient Problems Hyperglycemia (1905); Deformity/ Disfigurement (2360); Disability (2371)
Event Date 12/14/2016
Event Type  Injury  
Event Description

I've had 6 hernia surgeries. Started to remove a diseased colon, university of (b)(6) physicians got in there and had to remove a foot and a half of my intestine that had attached to original hernia surgery. Four of the six were on recall. Now i'm a 100% disabled, total deformed, have to rely on family to help, have grabbers in all rooms, in need of reconstruction wall surgery. No insurance until (b)(6) 2020, basically my intestine are hanging out of my stomach only holding in by very thin skin, wings. I could send pictures. Also went to the (b)(6) clinic in (b)(6) looking for answers, told me i was border diabetic of a surgery level over 600. Mind you just got out of the university of (b)(6) 4 months prior, either they didn't know; within that short period of time i became diabetic. I was told to get my a1c below 7 which i did lose a few pounds, only for them to take my insurance, approved (b)(6) and (b)(6) with (b)(6) a month spend down only receive (b)(6) a month disability. So insurance i did have for (b)(6) a month said well since you have (b)(6), your insurance will be (b)(6) a month, lol. I have 3 high school kids and house, car payments so their for no insurance. I need help, my life is in life threatening danger and they want to play politics all over 6 hernia repairs gone wrong. Help. Fda safety report id# (b)(4).

 
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Brand NameHERNIA MESH
Type of DeviceMESH, SURGICAL, POLYMERIC
Manufacturer (Section D)
BARD / DAVOL INC., SUB C.R BARD, INC.
MDR Report Key9341274
MDR Text Key167174344
Report NumberMW5091149
Device Sequence Number1
Product Code FTL
Combination Product (Y/N)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation PATIENT
Type of Report Initial
Report Date 11/15/2019
6 DeviceS WERE Involved in the Event: 1   2   3   4   5   6  
1 Patient Was Involved in the Event
Date FDA Received11/18/2019
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device MODEL NumberIN MY MEDICAL RECORDS
Device Catalogue NumberIN MY MEDICAL RECORDS
Device LOT NumberIN MY MEDICAL RECORDS
Was Device Available For Evaluation? Yes
Is The Reporter A Health Professional? No Answer Provided
Was the Report Sent to FDA?
Event Location No Information
Was Device Evaluated By Manufacturer? No Answer Provided
Is The Device Single Use? No Answer Provided
Is this a Reprocessed and Reused Single-Use Device?
Type of Device Usage

Patient TREATMENT DATA
Date Received: 11/18/2019 Patient Sequence Number: 1
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