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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: COVIDIEN PARIETEX PLUG AND PATCH SYSTEM; MESH SURGICAL POLYMERIC
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COVIDIEN PARIETEX PLUG AND PATCH SYSTEM; MESH SURGICAL POLYMERIC Back to Search Results
Model Number PNP6X3
Device Problem Migration or Expulsion of Device (1395)
Patient Problems Pain (1994); Scar Tissue (2060); Burning Sensation (2146); Discomfort (2330); No Code Available (3191)
Event Date 10/05/2018
Event Type  Injury  
Event Description
Reporter filing for her husband who had right inguinal hernia repair and was implanted with the plug and patch system on (b)(6) 2018.It is a same day procedure and upon discharge, he complained of severe pain, burning sensation, deep groin pain, discomfort and delayed voiding.One week post op he met with physician who said everything looks file.Two weeks after that visit he met with the family physician who physically evaluated him and said it feels like the mesh has migrated and he could also feel scar tissue formation.Two different physicians have examined him and they both said the same thing.This means a possible revision is on the way.He is yet to get relevant tests and scans.He was seen at the (b)(6).
 
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Brand Name
PARIETEX PLUG AND PATCH SYSTEM
Type of Device
MESH SURGICAL POLYMERIC
Manufacturer (Section D)
COVIDIEN
MDR Report Key8125090
MDR Text Key129317889
Report NumberMW5081784
Device Sequence Number1
Product Code FTL
UDI-Device Identifier20884521176420
UDI-Public20884521176420
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Non-Healthcare Professional
Type of Report Initial
Report Date 11/30/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/30/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator No Information
Device Model NumberPNP6X3
Device Catalogue NumberPNP6X3
Device Lot NumberHSR10198X
Is the Reporter a Health Professional? No
Was Device Evaluated by Manufacturer? No Information
Type of Device Usage N
Patient Sequence Number1
Patient Outcome(s) Other;
Patient Age57 YR
Patient Weight79
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