MAUDE Adverse Event Report: COVIDIEN LP LLC NORTH HAVEN UNKNOWN PROTACK; LAPAROSCOPE, GENERAL & PLASTIC SURGERY

Model Number UNKNOWN PROTACK

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.

• Brand Name: UNKNOWN PROTACK
• Type of Device: LAPAROSCOPE, GENERAL & PLASTIC SURGERY
• 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 Key: 8800941
• MDR Text Key: 151416511
• Report Number: 1219930-2019-04198
• Device Sequence Number: 1
• Product Code: GCJ
• Combination Product (y/n): N
• Reporter Country Code: SP
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,l
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 07/17/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: UNKNOWN PROTACK
• Device Catalogue Number: UNKNOWN PROTACK
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/01/2019
• Initial Date FDA Received: 07/17/2019
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 61 YR