• 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-TEX SOFT TISSUE PATCH 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-TEX SOFT TISSUE PATCH MESH, SURGICAL, POLYMERIC Back to Search Results
Device Problems Contamination (1120); Improper or Incorrect Procedure or Method (2017); Adverse Event Without Identified Device or Use Problem (2993); Insufficient Information (3190)
Patient Problem Unspecified Infection (1930)
Event Date 02/10/1992
Event Type  Injury  
Manufacturer Narrative

Additionally, event information such as item/lot number, implant date, date of explant, patient medical history were requested, however no information has been received. According to the instructions for use (ifu) for gore-tex® soft tissue patch complications may include but are not limited to, infection, inflammation, adhesion, fistula formation, seroma formation, perforation, wound dehiscence, wound complications, pain, bowel obstruction, ileus, revision/re-intervention, fever and recurrence.

 
Event Description

The following literature article was reviewed, "reconstruction of the chest wall with e-ptfe following major resection. " the article reports a chest wall reconstruction was performed with an expanded polytetrafluroethylene (e-ptfe) gore-tex® soft tissue patch (gore-tex)and vascularized flaps in all patients. The article reported perioperative antibiotics were used in all patients. The article reported reconstruction of the skeletal defect and stabilization of the chest wall was performed with a 2 mm gore-tex® soft tissue patch in all patients. The article reported during the perioperative period, none of the patients developed an infection of the gore-tex patch. However, 10 months postoperatively, one of the patients did develop a late infection involving the patch. The patch was easily removed.

 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameGORE-TEX SOFT TISSUE PATCH
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 Key9649312
MDR Text Key189353970
Report Number3003910212-2020-00013
Device Sequence Number1
Product Code FTL
Combination Product (Y/N)N
Reporter Country CodeUS
PMA/PMN NumberK963619
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Reporter Occupation
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 Received01/30/2020
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: 01/30/2020 Patient Sequence Number: 1
-
-