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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: COVIDIEN SURGIPRO MESH MESH, SURGICAL, POLYMERIC

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COVIDIEN SURGIPRO MESH MESH, SURGICAL, POLYMERIC Back to Search Results
Device Problems Defective Device (2588); Migration (4003)
Patient Problems Inflammation (1932); Pain (1994); Burning Sensation (2146); Hernia (2240); Discomfort (2330); Swelling/ Edema (4577)
Event Type  Injury  
Event Description

Had emergency surgery; i'm not exactly sure on the initial dates, i had hernia surgery , with surgipro mesh from covidien. Shortly after this surgery i started having pain and occasional burning feeling in the region. This continued to get worse and worse, i had epididymitis problems, and then developed the re occurring hernia that was bulging. A second surgery discovered the failed mesh had grown into my bladder. This surgery was now was extensive cutting out the defective mesh, and repairing the hernia. A catheter was inserted. I awoke in a hospital room and had to start my healing process, living with the discomfort of the organ repair. I am currently involved in a mass tort case vs covidien. Fda safety report id# (b)(4).

 
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Brand NameSURGIPRO MESH
Type of DeviceMESH, SURGICAL, POLYMERIC
Manufacturer (Section D)
COVIDIEN
MDR Report Key11506662
MDR Text Key240689789
Report NumberMW5100044
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 03/13/2021
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received03/16/2021
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: 03/16/2021 Patient Sequence Number: 1
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