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

MAUDE Adverse Event Report: JOHNSON & JOHNSON / ETHICON INC. HERNIA MESH 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
 

JOHNSON & JOHNSON / ETHICON INC. HERNIA MESH MESH, SURGICAL, POLYMERIC Back to Search Results
Device Problem Patient-Device Incompatibility (2682)
Patient Problems Adhesion(s) (1695); Emotional Changes (1831); Overdose (1988); Pain (1994); Scarring (2061); Urinary Frequency (2275); Depression (2361); Obstruction/Occlusion (2422); Ambulation Difficulties (2544)
Event Type  Injury  
Event Description

"anorexia 4 scares on stomach"; continue of adhesion on growth, morphine over dose or fentanyl patch. Depression take control of my life and no relationship; 12 tumors removed from my colon, constant pain. Bowel obstruction, hysterectomy, 3 times i had partial appendix removed. Life continuation of adhesions growth, constant urination, couldn't have children, suicidal thoughts. Stop using this product, i can't. I've been suicidal to this date 2020. I was given a hernia mesh in my pelvic area. I have incision marks all over my stomach. I had over a total of 85 staples or more. I can't walk at times. Reason for use: hernia mesh in my pelvic area, ongoing scar tissue. Did the problem stop after the person reduced the dose or stopped taking or using the product? no.

 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameHERNIA MESH
Type of DeviceMESH, SURGICAL, POLYMERIC
Manufacturer (Section D)
JOHNSON & JOHNSON / ETHICON INC.
MDR Report Key10539785
MDR Text Key207131684
Report NumberMW5096644
Device Sequence Number1
Product Code FTL
Combination Product (Y/N)
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation UNKNOWN
Type of Report Initial
Report Date 09/16/2020
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received09/16/2020
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator NO INFORMATION
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: 09/16/2020 Patient Sequence Number: 1
Treatment
DELTIAZEM ; FENTANYL 25 MG; FLUOXETINE 20 MG; GABAPENTIN 600 MG; GLATIRAMER 40 MG; GLUTATHIONE; LATANOPROST ; LEVOTHYROXINE 25 MG; NABUMETONE; RANITIDINE 20 MG; SIMVASTATIN ; SYMBICOT
-
-