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

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).

• Brand Name: HERNIA MESH
• Type of Device: MESH, SURGICAL, POLYMERIC
• Manufacturer (Section D): BARD / DAVOL INC., SUB C.R BARD, INC.
• MDR Report Key: 9341274
• MDR Text Key: 167174344
• Report Number: MW5091149
• Device Sequence Number: 2
• Product Code: FTL
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• 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 Received: 11/18/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: IN MY MEDICAL RECORDS
• Device Catalogue Number: IN MY MEDICAL RECORDS
• Device Lot Number: IN MY MEDICAL RECORDS
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Life Threatening; Disability
• Patient Age: 50 YR
• Patient Weight: 109