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U.S. Department of Health and Human Services

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

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W. L. GORE & ASSOCIATES, INC. GORE-TEX SOFT TISSUE PATCH MESH, SURGICAL, POLYMERIC Back to Search Results
Device Problem Insufficient Information (3190)
Patient Problem Unspecified Infection (1930)
Event Date 06/01/2004
Event Type  Injury  
Manufacturer Narrative

Product identification records for the alleged gore device were not provided. Therefore, a review of the manufacturing records could not be performed. It should be noted that the gore-tex® soft tissue patch  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. " the gore-tex® soft tissue patch instructions for use also states: ¿strict aseptic techniques should be followed. If an infection develops, it should be treated aggressively. An unresolved infection may require removal of the material. ".

 
Event Description

It was reported to gore that the patient underwent an unknown type of hernia repair on an unknown date whereby an gore-tex® soft tissue patch was allegedly implanted. The complaint alleges that in the summer of 2004, an additional procedure occurred whereby the gore device was explanted. It was reported the patient alleges the following injuries: infection, mrsa, pain and suffering, physical and emotional effects, and scarring. Additional event specific information was not provided.

 
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Brand NameGORE-TEX SOFT TISSUE PATCH
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
megan reigh
1505 n. fourth street
flagstaff, AZ 86004
9285263030
MDR Report Key12240409
MDR Text Key264058828
Report Number2017233-2021-02201
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
Source Type CONSUMER
Reporter Occupation
Type of Report Initial
Report Date 07/28/2021
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received07/28/2021
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?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received06/29/2021
Was Device Evaluated By Manufacturer? No Answer Provided
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: 07/28/2021 Patient Sequence Number: 1
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