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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SOFRADIM PARIETEX PROGRIP MESH
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SOFRADIM PARIETEX PROGRIP MESH Back to Search Results
Device Problem Insufficient Information (3190)
Patient Problem Pain (1994)
Event Date 08/07/2013
Event Type  Injury  
Event Description
Had an inguinal hernia repair (b)(6) 2013 where parietex progrip mesh was used and after 3 to 4 weeks, i developed extreme debilitating pain at the surgery site and into the groin area. After many attempts to relieve the pain through pain management, with little to no relief, in (b)(6) of 2014, i had a second surgery to remove the mesh.
 
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Brand NamePARIETEX PROGRIP MESH
Type of DevicePARIETEX PROGRIP MESH
Manufacturer (Section D)
SOFRADIM
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MDR Report Key4386930
MDR Text Key16305190
Report NumberMW5039928
Device Sequence Number1
Product Code FTL
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Patient
Type of Report Initial
Report Date 12/30/2014
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/30/2014
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Other Device ID NumberL0G15972
Was the Report Sent to FDA? No

Patient Treatment Data
Date Received: 12/30/2014 Patient Sequence Number: 1
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