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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: COVIDIEN/ SOFRADIM PARIETEX HERNIA MESH

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COVIDIEN/ SOFRADIM PARIETEX HERNIA MESH Back to Search Results
Model Number 60566569
Device Problems Migration or Expulsion of Device (1395); Device Operates Differently Than Expected (2913)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 12/02/2009
Event Type  Injury  
Event Description
Hernia mesh failed needed new surgery on (b)(6) 2010. Used paritex mesh. First mesh was not found when they did 2 surgeries. Just had a cat scan done and they found it at the bottom of my stomach.
 
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Brand NamePARIETEX HERNIA MESH
Type of DevicePARIETEX HERNIA MESH
Manufacturer (Section D)
COVIDIEN/ SOFRADIM
MDR Report Key6559912
MDR Text Key75011443
Report NumberMW5069693
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 05/09/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/09/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model Number60566569
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: 05/09/2017 Patient Sequence Number: 1
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