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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: COVIDIEN LP LLC NORTH HAVEN SURGIPRO; MESH, SURGICAL, POLYMERIC
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COVIDIEN LP LLC NORTH HAVEN SURGIPRO; MESH, SURGICAL, POLYMERIC Back to Search Results
Model Number UNKNOWN SURGIPRO MESH
Device Problems Adverse Event Without Identified Device or Use Problem (2993); Insufficient Information (3190)
Patient Problems Hematoma (1884); Unspecified Infection (1930); Pain (1994); Seroma (2069); No Consequences Or Impact To Patient (2199); No Code Available (3191)
Event Date 12/28/2019
Event Type  Injury  
Manufacturer Narrative
Title: abdominal wall closure with prophylactic mesh in colorectal operations source: anz j surg 90 (2020) 564¿568 published: 28 december 2019.(b)(4).If information is provided in the future, a supplemental report will be issued.
 
Event Description
According to literature source of study performed from 2008 to 2018, postoperative from midline laparotomy with bowel resection, 5 patients had infection, 1 patient had mesh removal, 8 patients had seroma in which 4 were subsequently drained, 8 patients had persisting pain and 3 patients had hematoma in which 2 required surgery.For the patients who underwent ileostomy reversal, 3 patients had infection, 1 patient had seroma which was subsequently drained, 4 patients had persisting pain and 1 patient had hematoma which required surgery.Article: jean wong, julia jones, 2019, saikrishna ananthapadmanabhan and alan p.Meagher, abdominal wall closure with prophylactic mesh in colorectal operations.
 
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Event Description
According to literature source of study performed from 2008 to 2018, postoperative from midline laparotomy with bowel resection, 5 patients had infection, 1 patient had mesh removal, 8 patients had seroma in which 4 were subsequently drained, 8 patients had persisting pain and 3 patients had hematoma in which 2 required surgery.For the patients who underwent ileostomy reversal, 3 patients had infection, 1 patient had seroma which was subsequently drained, 4 patients had persisting pain and 1 patient had hematoma which required surgery.These complications were not related to the device reported.
 
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Brand Name
SURGIPRO
Type of Device
MESH, SURGICAL, POLYMERIC
Manufacturer (Section D)
COVIDIEN LP LLC NORTH HAVEN
195 mcdermott rd
north haven CT 06473
MDR Report Key10599137
MDR Text Key208926875
Report Number1219930-2020-04018
Device Sequence Number1
Product Code FTL
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,health professional,l
Type of Report Initial,Followup
Report Date 10/30/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/29/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model NumberUNKNOWN SURGIPRO MESH
Device Catalogue NumberUNKNOWN SURGIPRO MESH
Was Device Available for Evaluation? No
Date Manufacturer Received10/13/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
Patient Age65 YR
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