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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 UNKNOWN PARIETEX
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Hematoma (1884); Pain (1994); Seroma (2069); Obstruction/Occlusion (2422); Post Operative Wound Infection (2446); No Code Available (3191)
Event Date 11/02/2010
Event Type  Injury  
Manufacturer Narrative

(b)(4). Title results of laparoscopic repair of primary and recurrent incisional hernias at a single uk institution source surg laparosc endosc percutan tech 2011;21:86¿89. Volume 21, number 2, april 2011. If information is provided in the future, a supplemental report will be issued.

 
Event Description

According to literature source of study performed at a single uk institution between 1994 and 2008 with incisional hernia repairs were analyzed with respect to short-term and long-term results. Prospectively collected data were analyzed retrospectively to ascertain outcomes, complications, and recurrences. Two hundred and twenty-seven operations were performed in 212 patients (128 female) with 35% of the operations being for recurrent hernias. In early patients polypropylene mesh was used; however, from 2006 to 2007 a composite polyester mesh incorporating a layer of resorbable collagen was usually used to reduce the risk of adhesion formation to the visceral side of the mesh. After circumferential fixation with spiral metal tacks (the omentum was interposed between the mesh and underlying viscera, wherever possible. Complications were not separated based on which were related to which mesh or whether it was due to the tacker. There were 52 complications (23%) including 30 symptomatic seromas or hematomas and 5 minor wound infections. There were 3 postoperative bleeds, 2 of which required laparotomy. Three mesh infections required laparotomy to remove the mesh, at least one of which was probably because of an unrecognized enterotomy at the time of initial surgery. Eight patients complained of chronic pain postoperatively. One patient developed a postoperative ileus, which settled with conservative management. Four patients developed small bowel obstruction postoperatively of which 2 required laparotomy and adhesiolysis. In all there were 25 recurrences (11%), being detected a median of 17 months after the initial operation.

 
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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 Key8800935
MDR Text Key151418362
Report Number1219930-2019-04197
Device Sequence Number1
Product Code FTL
Combination Product (Y/N)N
Reporter Country CodeUK
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type FOREIGN,HEALTH PROFESSIONAL,L
Reporter Occupation
Type of Report Initial
Report Date 07/17/2019
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received07/17/2019
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device MODEL NumberUNKNOWN PARIETEX
Device Catalogue NumberUNKNOWN PARIETEX
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received07/01/2019
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: 07/17/2019 Patient Sequence Number: 1
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