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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: COVIDIEN LP LLC NORTH HAVEN PARIETEX MESH, SURGICAL, POLYMERIC

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COVIDIEN LP LLC NORTH HAVEN PARIETEX MESH, SURGICAL, POLYMERIC Back to Search Results
Model Number PCO9FX
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Abscess (1690); Adhesion(s) (1695); Emotional Changes (1831); Unspecified Infection (1930); Inflammation (1932); Irritation (1941); Itching Sensation (1943); Nausea (1970); Pain (1994); Scar Tissue (2060); Scarring (2061); Hot Flashes/Flushes (2153); No Code Available (3191); Skin Inflammation/ Irritation (4545)
Event Date 09/04/2020
Event Type  Injury  
Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

 
Event Description

According to the reporter, post-operative an umbilical hernia repair when the mesh was implanted, the patient since then had major problems, 4 operations and now 5th for the removal. Post-operative complications include: chronic pain, chronic inflammation and irritation, infection, abscess, neuro-muscular problems, bowel adhesion, scarring, pins and needles constant. There was also constant nausea, brain fog, related emotional problems, itchy skin, lost of sex drive, hot flashes, the patient's stomach area was hard and the area of the belly button could no longer be touched. The patient now could not sit longer than an hour or drive long distance because it would make the pain worse and then would required to patient to rest for two days. The patient could no longer do normal shopping. The patient would need to go in and out as if standing for too long, and then the pain and nausea would set in. In most nights the patient would sleep more or less 3 hours with broken sleep.

 
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Brand NamePARIETEX
Type of DeviceMESH, SURGICAL, POLYMERIC
Manufacturer (Section D)
COVIDIEN LP LLC NORTH HAVEN
195 mcdermott rd
north haven CT 06473
Manufacturer (Section G)
COVIDIEN LP LLC NORTH HAVEN
195 mcdermott rd
north haven CT 06473
Manufacturer Contact
lisa hernandez
60 middletown ave.
north haven, CT 06473
2034925563
MDR Report Key10767243
MDR Text Key214103189
Report Number1219930-2020-04573
Device Sequence Number1
Product Code FTL
Combination Product (Y/N)N
PMA/PMN NumberK110663
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type OTHER
Reporter Occupation
Type of Report Initial,Followup
Report Date 12/30/2020
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received10/31/2020
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device MODEL NumberPCO9FX
Device Catalogue NumberPCO9FX
Device LOT NumberPC09FX
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received12/08/2020
Was Device Evaluated By Manufacturer? No Answer Provided
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient TREATMENT DATA
Date Received: 10/31/2020 Patient Sequence Number: 1
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