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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: COVIDIEN PARIETEX SURGICAL MESH

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COVIDIEN PARIETEX SURGICAL MESH Back to Search Results
Device Problem Device Operates Differently Than Expected (2913)
Patient Problems Nausea (1970); Vomiting (2144); Abdominal Cramps (2543); Constipation (3274)
Event Date 10/01/2014
Event Type  Injury  
Event Description

On (b)(6) 2014 i had a ventral hernia repaired using parietex mesh using secure-strap. Initially, i felt soreness, as expected from the surgery. Approximately, 5-6 months after the surgery i started feeling the same signs and symptoms as i did with the ventral hernia. Two and a half years have passed and i am still having nausea, vomiting, constipation and severe abdominal cramps.

 
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Brand NamePARIETEX
Type of DeviceSURGICAL MESH
Manufacturer (Section D)
COVIDIEN
MDR Report Key6215325
MDR Text Key63724945
Report NumberMW5066986
Device Sequence Number1
Product Code FTL
Combination Product (Y/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 12/28/2016
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received12/28/2016
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator NO INFORMATION
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? No Answer Provided
Is The Device Single Use? No Answer Provided
Is this a Reprocessed and Reused Single-Use Device?
Type of Device Usage

Patient TREATMENT DATA
Date Received: 12/28/2016 Patient Sequence Number: 1
Treatment
COLACE; OTC MEDS: MULTIVITAMIN; PEPCID; PEPTO BISMOL; RX MEDS: PARIETEX MESH; SIMETHACONE; VITAMIN B12; VITAMIN D
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