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U.S. Department of Health and Human Services

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

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COVIDIEN COVIDIEN PARIETEX PROGRIP MESH MESH, SURGICAL, POLYMERIC Back to Search Results
Device Problem Insufficient Information (3190)
Patient Problems Fainting (1847); Muscle Spasm(s) (1966); Pain (1994); Swelling (2091); Vomiting (2144); Chills (2191); Sweating (2444); Ambulation Difficulties (2544); Abdominal Distention (2601); Constipation (3274)
Event Date 12/18/2018
Event Type  Injury  
Event Description

I had right femoral hernia repair on (b)(6) 2018 at (b)(6) in (b)(6), surgeon used progrip mesh. I had pain, swelling, constipation, pelvic spasms, inability to walk, sit, work, could not wipe myself, incomplete bowel movements, bloating, swelling, vomiting, fainting, chills and night sweats. Deep ache pain with shooting pain into my labia and into my right inner thigh. Pain was not controlled by pain medications. I was on bed rest until i had the mesh removed on (b)(6) 2019 at same hosp by original surgeon.

 
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Brand NameCOVIDIEN PARIETEX PROGRIP MESH
Type of DeviceMESH, SURGICAL, POLYMERIC
Manufacturer (Section D)
COVIDIEN
MDR Report Key8473943
MDR Text Key140809636
Report NumberMW5085506
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 03/28/2019
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received04/01/2019
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Was Device Available For Evaluation? No
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: 04/01/2019 Patient Sequence Number: 1
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