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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: COVIDIEN PARIETEX PROGRIP MESH

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COVIDIEN PARIETEX PROGRIP MESH Back to Search Results
Device Problem Patient-Device Incompatibility (2682)
Patient Problems Chest Pain (1776); Hemorrhage/Bleeding (1888); Nerve Damage (1979); Ambulation Difficulties (2544); No Code Available (3191)
Event Date 09/24/2014
Event Type  Injury  
Event Description
Reporter states that, from day one of his hernia mesh placement, he has had hematoma with excessive internal bleeding, and still experiencing the following conditions; testicular nerve damage, intestinal nerve damage from multiple adhesions, nerve pain from his testicles up to his chest, his back, down to his groin area and around his knees. Reporter states that some days the pain is so excruciating that he can not even walk and causing him bowel movement problems that led to small and big bowel test being done. Reporter says his surgeons are telling him that the only way to stop his pain is to have orchiectomy. Reporter says he feels like he is being poisoned and often nauseous without any cause. Reporter says per medical advise, he has to have endoscopic procedure once a year to see if the adhesions are multiplying. Reporter would like to know if other people are reporting about this device and if yes, has the device been recalled by fda and if not why is fda waiting to take it off the market.
 
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Brand NamePARIETEX PROGRIP
Type of DeviceMESH
Manufacturer (Section D)
COVIDIEN
MDR Report Key6871654
MDR Text Key86618925
Report NumberMW5072164
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 09/15/2017
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received09/15/2017
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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