• 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
Device Problems Contamination (1120); Device Appears to Trigger Rejection (1524); Insufficient Information (3190)
Patient Problem Seroma (2069)
Event Date 11/28/2006
Event Type  Injury  
Manufacturer Narrative

Adverse reactions in the instructions for use (ifu) for gore® dualmesh® biomaterial state the following: as with any surgical procedure, there are always risks of complications in surgical repair of soft tissue deficiencies, with or without mesh. Complications may include but are not limited to, infection, inflammation, adhesion, fistula formation, seroma formation, perforation, wound dehiscence, would complications, pain, bowel obstruction, ileus, revision/re-intervention, fever and recurrence.

 
Event Description

The following literature article was reviewed, "the comparison of laparoscopic and open ventral hernia repairs: a prospective randomized study. " the article reports between january 2001 and october 2005, a total of 46 patients diagnosed with ventral hernias (primary and incisional) were examined. Twenty-three patients underwent laparoscopic repair during this interval, while another 23 patients underwent open ventral hernia surgery. The article reports for one patient, who had been receiving warfarin for her prosthetic heart valve, aspirative drainage and oral antibiotic treatment were employed. The article reported she developed a haematoma in her remnant hernial sac postoperatively and it was drained percutaneously. The article reports persistent serous leakage on the trans facial suture site occurred over a 6 month period during the follow- ups. The results of the fluid were negative for infection. The article reported one patient in the laparoscopy group, where control abdominal tomography showed that the intact graft had integrated into the abdominal wall and there were no signs of an enterocutaneous fistula. The e-ptfe gore® dualmesh® biomaterial graft was removed, together with the fistula tract. Since all test results were negative for infection, the final diagnosis was graft rejection.

 
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
angela brown
1500 n. 4th street
9285263030
MDR Report Key10084434
MDR Text Key192155997
Report Number3003910212-2020-00102
Device Sequence Number1
Product Code FTL
Combination Product (Y/N)N
Reporter Country CodeTU
PMA/PMN NumberK992189
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Reporter Occupation
Type of Report Initial,Followup
Report Date 07/06/2020
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received05/22/2020
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator HEALTH PROFESSIONAL
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
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: 05/22/2020 Patient Sequence Number: 1
-
-