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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: COVIDIEN PARIETEX PLUG AND PATCH PNP6X3 MESH, SURGICAL, POLYMERIC

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COVIDIEN PARIETEX PLUG AND PATCH PNP6X3 MESH, SURGICAL, POLYMERIC Back to Search Results
Model Number PNP6X3
Device Problems Entrapment of Device (1212); Difficult to Remove (1528)
Patient Problem Pain (1994)
Event Date 11/22/2016
Event Type  Injury  
Event Description
On the above date i had my first hernia surgery and the hernia mesh was implanted. At that time i had a lot of pain and, on (b)(6) 2017, about a year the surgeon tried to remove the mesh, but he told me only half of it was removed. As it was already ingrown with the tissue. Because of a lot of pain, i had a third surgery in 2018, but the difference from the first two surgeries was that this one was laparoscopic. The first open, all went well, but i still had (and still have) pain and i asked the surgeon what the problem was, he said that the problematic mesh from the first surgery has migrated. Removal can probably be done, but with a huge risk of removing. The closest to the mesh testicle, i am terrified. Fda safety report id# (b)(4).
 
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Brand NamePARIETEX PLUG AND PATCH PNP6X3
Type of DeviceMESH, SURGICAL, POLYMERIC
Manufacturer (Section D)
COVIDIEN
MDR Report Key10148223
MDR Text Key195104263
Report NumberMW5094961
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 06/09/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/11/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberPNP6X3
Device Catalogue NumberPNP6X3
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?
Is the Device Single Use?
Is This a Reprocessed and Reused Single-Use Device?
Type of Device Usage

Patient Treatment Data
Date Received: 06/11/2020 Patient Sequence Number: 1
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