• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

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

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

BARD SHANNON LIMITED HERNIA PATCH MESH, SURGICAL, POLYMERIC Back to Search Results
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).
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameHERNIA PATCH
Type of DeviceMESH, SURGICAL, POLYMERIC
Manufacturer (Section D)
BARD SHANNON LIMITED
MDR Report Key12446999
MDR Text Key271006096
Report NumberMW5103805
Device Sequence Number1
Product Code FTL
Reporter Country CodeUS
Number of Events Reported1
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 Received09/08/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
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?
Is the Device Single Use?
Is This a Reprocessed and Reused Single-Use Device?
Type of Device Usage

Patient Treatment Data
Date Received: 09/08/2021 Patient Sequence Number: 1
-
-