• 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 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 GORE DUALMESH BIOMATERIAL MESH, SURGICAL, POLYMERIC Back to Search Results
Model Number 1DLMC07
Device Problems Contamination (1120); Improper or Incorrect Procedure or Method (2017); Insufficient Information (3190)
Patient Problems Purulent Discharge (1812); Fistula (1862); Granuloma (1876); Unspecified Infection (1930); Seroma (2069); Discharge (2225)
Event Date 08/31/2017
Event Type  Injury  
Manufacturer Narrative
(b)(6). It should be noted that the gore dualmesh® biomaterial instructions for use includes warnings and addresses the following adverse reactions among others: ¿strict aseptic techniques should be followed. If an infection develops, it should be treated aggressively. An unresolved infection may require removal of the material. ¿ ¿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 incisional hernia repair on (b)(6) 2014 whereby a gore dualmesh® biomaterial was implanted. The complaint alleges that on (b)(6) 2017, an additional procedure was performed whereby explant of the gore device was performed. It was reported the patient alleges the following injuries: open draining wound, granuloma, infected mesh, mesh removal. Additional event specific information and medical records have been requested.
 
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
flagstaff AZ
Manufacturer (Section G)
MPD APC B/P
p.o. box 1408
elkton MD 21922 1408
Manufacturer Contact
kathy titus
1500 n. 4th street
flagstaff, AZ 
9285263030
MDR Report Key7641345
MDR Text Key112443235
Report Number3003910212-2018-00054
Device Sequence Number1
Product Code FTL
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K992189
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Reporter Occupation Other Caregivers
Type of Report Initial,Followup,Followup,Followup,Followup
Report Date 08/03/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/27/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date08/31/2018
Device Model Number1DLMC07
Device Catalogue Number1DLMC07
Device Lot Number11777873
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Event Location No Information
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured09/25/2013
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: 06/27/2018 Patient Sequence Number: 1
-
-