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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: HERNIA MESH MESH, SURGICAL, POLYMERIC

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HERNIA MESH MESH, SURGICAL, POLYMERIC Back to Search Results
Device Problem Patient-Device Incompatibility (2682)
Patient Problems Pain (1994); Burning Sensation (2146)
Event Date 08/07/2009
Event Type  Injury  
Event Description
I got a inguinal hernia repair around (b)(6) 2016 but i'm always in pain, burning and throbbing. How can i find out what kind of mesh i have? i was told i don't have a hernia but probably my body is rejecting the mesh. Fda safety report id# (b)(4).
 
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Brand NameHERNIA MESH
Type of DeviceMESH, SURGICAL, POLYMERIC
MDR Report Key8866467
MDR Text Key153696481
Report NumberMW5088843
Device Sequence Number1
Product Code FTL
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Patient
Type of Report Initial
Report Date 08/02/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/05/2019
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: 08/05/2019 Patient Sequence Number: 1
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