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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: COVIDIEN / MEDTRONIC INC. PARIETEX HERNIA MESH 20X30 CM MESH, SURGICAL, POLYMERIC
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COVIDIEN / MEDTRONIC INC. PARIETEX HERNIA MESH 20X30 CM MESH, SURGICAL, POLYMERIC Back to Search Results
Device Problem Detachment of Device or Device Component (2907)
Patient Problems Abdominal Pain (1685); Failure of Implant (1924); Scarring (2061); Hernia (2240); Numbness (2415); Ambulation Difficulties (2544); Weight Changes (2607); Dysuria (2684)
Event Date 07/30/2010
Event Type  Injury  
Event Description
Reporter stated that a laparoscopic surgery was performed and a hernia mesh was placed to repair an already existing hernia. Subsequently, the mesh detached / fell causing severe abdominal pain, difficulties urinating, numbness, and a return of the hernia. Reporter visited his dr who indicated that a reconstructive emergency surgery will be necessary to explant the mesh. The dr extracted some of the mesh fragments and was unable to extract the rest due to adhesion to the walls of his bowels and other vital organ. Reporter stated that after the surgery, he has scarring, urinary / sexual concerns, weight gain, ambulation difficulties, liver problems, inability to exercise and abdominal pain which still persists.
 
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Brand NamePARIETEX HERNIA MESH 20X30 CM
Type of DeviceMESH, SURGICAL, POLYMERIC
Manufacturer (Section D)
COVIDIEN / MEDTRONIC INC.
MDR Report Key8499993
MDR Text Key141579076
Report NumberMW5085717
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 04/09/2019
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received04/09/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Was Device Available for Evaluation? No Answer Provided
Is the Reporter a Health Professional? No
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

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