MAUDE Adverse Event Report: BARD SHANNON LIMITED HERNIA PATCH; MESH, SURGICAL, POLYMERIC

Device Problems Patient-Device Incompatibility (2682); Positioning Problem (3009); Unintended Movement (3026)

Patient Problems Abdominal Pain (1685); Fever (1858); Pain (1994); Depression (2361); Weight Changes (2607)

Event Date 08/29/2021

Event Type  Injury  

Event Description

Still have original hernia patch from 2005.I think it may be a bard patch.Put in (b)(6) 2005 by dr.(b)(6).I have not been contacted at all about the patch by the surgeon.I believe he is in (b)(6), practicing there.I think it has migrated? staples may have let go? i think it is a 10 inch size.I have not trusted this thing since it was placed in.I had a low-grade fever after surgery for a couple years.Told to return to work in just 4 weeks? not long enough, i did not think.My job was very physical.I cleaned a school.A labor job really.Now 16 years later i am experiencing pain in my abdomen.I have gained weight due to depression medication.A considerable amount of weight (b)(6) pounds heavier now? menopause has passed now and i feel horrible.I am just glad i did not get pregnant after this patch was put in.I would have been too afraid to have a baby.Not sure what to do at this point.I had it checked once right after the surgery and they said they could not see it so it may have still been ok.My doctor.Doctor (b)(6) has not sent me to get it checked.I did see a surgeon who said he would put one over top.I do not want that.(b)(6) also in (b)(6) where my doctor is.I think it could be infected.I am experiencing pain upon bending and working outdoors.I have pain that i do not understand in my abdomen.Kind of hurts to the touch.It could be infection.I want a surgeon that would not just put another one in but one that would look for staples too that were used to put it in.Not looking forward to any surgery.Did not want this placed inside me back in 2005.I was pretty shocked when i learned he actually put it in there.I wanted stitches.He said my organs were stuck together but that could be from child-rape.Yeah, i was 5.Now i may be needing it out.Robotic surgery seems to be the safest sounding one but not if staples are floating around inside me? any help would be appreciated.(b)(6) hernia patch check.Not positive on the date i had it checked there.Bard? 2005 placement.Fda safety report id # (b)(4).

• Brand Name: HERNIA PATCH
• Type of Device: MESH, SURGICAL, POLYMERIC
• Manufacturer (Section D): BARD SHANNON LIMITED
• MDR Report Key: 12446999
• MDR Text Key: 271006096
• Report Number: MW5103805
• Device Sequence Number: 1
• Product Code: FTL
• 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: 09/06/2021
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Date FDA Received: 09/08/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Was Device Available for Evaluation?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Disability
• Patient Age: 54 YR
• Patient Weight: 66