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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: W.L. GORE & ASSOCIATES GORE-TEX SOFT TISSUE PATCH MESH, SURGICAL, POLYMERIC

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W.L. GORE & ASSOCIATES GORE-TEX SOFT TISSUE PATCH MESH, SURGICAL, POLYMERIC Back to Search Results
Catalog Number 1415020010
Device Problems No Apparent Adverse Event (3189); Insufficient Information (3190)
Patient Problems Adhesion(s) (1695); Unspecified Infection (1930); No Information (3190); No Clinical Signs, Symptoms or Conditions (4582)
Event Date 10/25/2016
Event Type  Injury  
Manufacturer Narrative

(b)(6). It should be noted that the gore-tex® soft tissue patch instructions for use includes warnings and 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 a patient asserts a complaint arising from the implantation of a gore-tex® soft tissue patch device based on an unspecified alleged injury and/or alleged product deficiency. As no specific information was provided as to the patient¿s complaint about the gore-tex® soft tissue patch device, this event is being documented based on a general allegation of an unknown product deficiency and/or alleged injury.

 
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Brand NameGORE-TEX SOFT TISSUE PATCH
Type of DeviceMESH, SURGICAL, POLYMERIC
Manufacturer (Section D)
W.L. GORE & ASSOCIATES
flagstaff AZ
Manufacturer (Section G)
MEDICAL WOODY MOUNTAIN B/P
3750 w. kiltie lane
flagstaff AZ 86005
Manufacturer Contact
kathy titus
1500 n. 4th street
flagstaff, AZ 
9285263030
MDR Report Key7943957
MDR Text Key123067266
Report Number2017233-2018-00596
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,Followup,Followup,Followup
Report Date 04/12/2021
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received10/08/2018
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator HEALTH PROFESSIONAL
Device EXPIRATION Date11/28/2006
Device Catalogue Number1415020010
Device LOT Number01176014
Was Device Available For Evaluation? No
Is The Reporter A Health Professional?
Was the Report Sent to FDA? No
Event Location No Information
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured11/29/2001
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: 10/08/2018 Patient Sequence Number: 1
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