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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: COVIDIEN PARIETEX PROGRIP MESH, SURGICAL, POLYMERIC

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COVIDIEN PARIETEX PROGRIP MESH, SURGICAL, POLYMERIC Back to Search Results
Catalog Number TEM1208GL
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Diarrhea (1811); Headache (1880); Nausea (1970); Pain (1994); Anxiety (2328); Arthralgia (2355); Depression (2361); Constipation (3274)
Event Date 05/18/2014
Event Type  Injury  
Event Description

Pain in my left groin in leg, headaches, anxiety, joint aches and nausea, pain with sex, constipation/diarrhea, and depression.

 
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Brand NamePARIETEX PROGRIP
Type of DeviceMESH, SURGICAL, POLYMERIC
Manufacturer (Section D)
COVIDIEN
MDR Report Key8499892
MDR Text Key141521366
Report NumberMW5085712
Device Sequence Number0
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 04/01/2019
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received04/09/2019
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator LAY USER/PATIENT
Device EXPIRATION Date08/01/2017
Device Catalogue NumberTEM1208GL
Device LOT NumberSMI100312
Was Device Available For Evaluation? No Answer Provided
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: 04/09/2019 Patient Sequence Number: 1
Treatment
ATAZANAVIR 300MG DAILY; ONDANSETRON 4MG AS NEEDED; RITONAVIR 100MG DAILY; TRUVADA - 200/300MG DAILY
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