• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: W. L. GORE & ASSOCIATES, INC. GORE SEAMGUARD BIOABSORBABLE STAPLE LINE REINFORCEMENT MESH, SURGICAL

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

W. L. GORE & ASSOCIATES, INC. GORE SEAMGUARD BIOABSORBABLE STAPLE LINE REINFORCEMENT MESH, SURGICAL Back to Search Results
Device Problems Fluid Leak (1250); Insufficient Information (3190)
Patient Problem No Code Available (3191)
Event Date 01/01/2014
Event Type  Injury  
Manufacturer Narrative
According to the gore® seamguard® bioabsorbable staple line reinforcement instructions for use (ifu), adverse events that may occur and/or require intervention include, but are not limited to: infection, inflammation, adhesion and hematoma.
 
Event Description
The following publication which mentions gore® seamguard® bioabsorbable staple line reinforcement was reviewed: bioabsorbable staple line reinforcement in restorative proctectomy and anterior resection: a randomized study. Background: anastomotic complications, including leaks, strictures/stenosis, and bleeding, cause considerable mortality and morbidity after colorectal surgery. Methods: this study was conducted at 17 centers in the united states. The 258 patients 123 in the reinforcement group (gore® seamguard® circular bioabsorbable staple line reinforcement) and 135 control subjects underwent surgery for a variety of conditions, but most (n
=
200) were treated for rectal cancer. A double-stapled, circular-stapler anastomosis was performed in all of the patients. The diameter of the circular stapler (28 to 34 mm) was determined by the operating surgeon in each case. Results: one patient in the bslr group experienced stenosis (stricture) requiring a re-intervention.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameGORE SEAMGUARD BIOABSORBABLE STAPLE LINE REINFORCEMENT
Type of DeviceMESH, SURGICAL
Manufacturer (Section D)
W. L. GORE & ASSOCIATES, INC.
1505 n. fourth street
flagstaff AZ 86004
Manufacturer (Section G)
MPD APC B/P
p.o. box 1408
elkton MD 21922 1408
Manufacturer Contact
angela brown
1505 n. fourth street
flagstaff, AZ 86004
9285263030
MDR Report Key10248945
MDR Text Key198089393
Report Number3003910212-2020-01004
Device Sequence Number1
Product Code FTM
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type literature
Reporter Occupation
Type of Report Initial
Report Date 07/08/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received07/09/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
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 Received07/02/2020
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

-
-