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

MAUDE Adverse Event Report: ETHICON JOHNSON AND JOHNSON ETHICON PROLENE MESH ETHICON PROLENE HERNIA SYSTEM

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

ETHICON JOHNSON AND JOHNSON ETHICON PROLENE MESH ETHICON PROLENE HERNIA SYSTEM Back to Search Results
Lot Number JBF3229E
Event Date 07/14/2004
Event Type  Other  
Event Description

I had hernia surgery in (b)(6) 2004 and they put ethicon prolene mesh in me. I was fine until (b)(6). Now i have severe pain where the surgery was done and all the way down into my penis. I am sick to my stomach and hurt like a stabbing feeling and needles sticking me. Everything i read says it is the mesh but now i have no insurance and i am trying to hold on as long as possible but it is getting really hard to handle the pain much longer. I got my medical records from the surgery but i really don't know how to tell what mesh is recalled. I just know mine is hurting.

 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameJOHNSON AND JOHNSON ETHICON PROLENE MESH
Type of DeviceETHICON PROLENE HERNIA SYSTEM
Manufacturer (Section F)
ETHICON
Manufacturer (Section D)
ETHICON
Device Event Key2252248
MDR Report Key2226867
Event Key2123783
Report NumberMW5021888
Device Sequence Number1
Product CodeFTL
Report Source Voluntary
Reporter Occupation Patient
Type of Report Initial
Report Date 08/24/2011
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received08/24/2011
Is This An Adverse Event Report? No
Is This A Product Problem Report? No
Device Operator Health Professional
Device EXPIRATION Date07/31/2008
Device LOT NumberJBF3229E
Is The Reporter A Health Professional? No
Was The Report Sent To Manufacturer? No
Is this a Reprocessed and Reused Single-Use Device? No
Is the Device an Implant? Yes
Is this an Explanted Device?

Patient TREATMENT DATA
Date Received: 08/24/2011 Patient Sequence Number: 1
-
-