• 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 DUALMESH BIOMATERIAL MESH, SURGICAL, POLYMERIC

  • 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 DUALMESH BIOMATERIAL MESH, SURGICAL, POLYMERIC Back to Search Results
Model Number 1DLMC07
Device Problem Insufficient Information (3190)
Patient Problem No Code Available (3191)
Event Date 09/27/2010
Event Type  Injury  
Manufacturer Narrative

(b)(4). It should be noted that the gore® dualmesh® biomaterial instructions for use addresses the following adverse reactions among others: ¿possible adverse reactions with the use of any tissue deficiency prosthesis may include, but are not limited to, contamination, infection, inflammation, adhesion, fistula formation, seroma formation, hematoma, and recurrence. ".

 
Event Description

It was reported to gore that the patient underwent laparoscopic ventral hernia repair on (b)(6) 2007 whereby a gore® dualmesh® biomaterial was implanted. The complaint alleges that on (b)(6) 2010, an additional procedure occurred whereby the gore device was explanted. It was reported the patient alleges the following injuries: gore mesh was found to be wrinkled, laxed, and bulging giving a large bulge midline defect, mesh split vertically, the small bowel was dissected away from the underside of the mesh, gore mesh was re-approximated to repair the ventral hernia defect. Additional event specific information was not provided.

 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameGORE DUALMESH BIOMATERIAL
Type of DeviceMESH, SURGICAL, POLYMERIC
Manufacturer (Section D)
W. L. GORE & ASSOCIATES, INC.
1505 n. fourth street
flagstaff AZ 86004
Manufacturer (Section G)
MEDICAL WOODY MOUNTAIN B/P
3750 w. kiltie lane
flagstaff AZ 86005
Manufacturer Contact
heidi womble
1505 n. fourth street
flagstaff, AZ 86004
9285263030
MDR Report Key11124188
MDR Text Key225303810
Report Number2017233-2021-01579
Device Sequence Number1
Product Code FTL
Combination Product (Y/N)N
Reporter Country CodeUS
PMA/PMN NumberK992189
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type OTHER
Reporter Occupation
Type of Report Initial,Followup,Followup
Report Date 04/05/2021
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received01/06/2021
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator HEALTH PROFESSIONAL
Device EXPIRATION Date05/23/2011
Device MODEL Number1DLMC07
Device Catalogue Number1DLMC07
Was Device Available For Evaluation? No
Is The Reporter A Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received03/11/2021
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured05/24/2006
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: 01/06/2021 Patient Sequence Number: 1
-
-