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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: US SURGICAL / COVIDIEN S-MESH HERN EASEGRIP, PARIETEX EASEGRIP MESH SURGICAL MESH

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US SURGICAL / COVIDIEN S-MESH HERN EASEGRIP, PARIETEX EASEGRIP MESH SURGICAL MESH Back to Search Results
Catalog Number TET1208DL
Device Problem Migration or Expulsion of Device (1395)
Patient Problems Pain (1994); Numbness (2415); Collapse (2416); Ambulation Difficulties (2544); Foreign Body In Patient (2687)
Event Date 04/29/2008
Event Type  Injury  
Event Description
Had to have two hernia surgeries. First one, mesh got lost in my body, and by it migrating, it caused the stitch to severe my nerve causing groin area and down leg to be numb and very painful causing me problems walking and can't lift or put pressure on my leg. Mesh is still lost in my body and they were unable to find it with laparoscopic surgery, so paid for hernia to make me be in more pain and now i'm unable to walk or sit for long periods of time ease mesh us surgical for inguinal hernia. Some days i'm barely able to get out of bed without heavy pain killers and still in pain when surgery first happened, i collapsed at home after surgery because i couldn't feel my leg had to learn how to walk like a flamingo never pulling pressure on left leg which is now causing me hip, back and knee problems because we are not made to walk and hop on one leg what scares me is not knowing where the mesh is and hernia is still not repaired. I am just worse off for using migrating mesh. Product is lost in body.
 
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Brand NameS-MESH HERN EASEGRIP, PARIETEX EASEGRIP MESH
Type of DeviceSURGICAL MESH
Manufacturer (Section D)
US SURGICAL / COVIDIEN
MDR Report Key6575602
MDR Text Key75536898
Report NumberMW5069847
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 05/16/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/16/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date12/30/2012
Device Catalogue NumberTET1208DL
Device Lot NumberSHL000396
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: 05/16/2017 Patient Sequence Number: 1
Treatment
FENTANYL PATCHES; OXYCODONE
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