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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
Model Number 1310015020
Device Problem Insufficient Information (3190)
Patient Problems Abscess (1690); Unspecified Infection (1930)
Event Date 12/21/2012
Event Type  Injury  
Manufacturer Narrative

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 open incisional hernia repair on (b)(6) 2003 whereby a gore-tex® soft tissue patch was implanted. The complaint alleges that on (b)(6) 2012, an additional procedure occurred whereby the gore device was explanted. It was reported the patient alleges the following injuries: abscess, infection, and explant. Removal due to large infection, abscess, fluid collection. 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
heidi womble
1505 n. fourth street
flagstaff, AZ 86004
9285263030
MDR Report Key11569993
MDR Text Key242766747
Report Number2017233-2021-01807
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 OTHER
Reporter Occupation
Type of Report Initial,Followup
Report Date 04/15/2021
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received03/25/2021
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator HEALTH PROFESSIONAL
Device EXPIRATION Date07/09/2006
Device MODEL Number1310015020
Device Catalogue Number1310015020
Was Device Available For Evaluation? No
Is The Reporter A Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received03/20/2021
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured07/10/2001
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: 03/25/2021 Patient Sequence Number: 1
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