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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 03/21/2017
Event Type  Injury  
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) 2017, an additional procedure occurred whereby the gore device was explanted. It was reported the patient alleges the following injuries: infection. Additional event specific information was not provided.
 
Manufacturer Narrative
(b)(4). 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. " w. L. Gore & associates, inc. (gore) is submitting this report to comply with 21 c. F. R. Part 803, the medical device reporting regulation. This report is based upon information obtained by gore, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda. Blank fields present on this report include required fields and fields determined to be not applicable. Blank required fields indicate that the information was not provided, was deemed unavailable or was not applicable. This report does not constitute an admission or a conclusion by fda, gore, or its associates that the device, gore or its associates caused or contributed to the event described in the report. In particular, this report does not constitute a legal admission by anyone that the product described in this report has any defects or has malfunctioned, as defined from a legal standpoint. These words are included in the report and are fixed items for selection created by the fda, to categorize the type of event solely for the purpose of reporting pursuant to part 803. This statement should be included with any information or report disclosed to the public under the freedom of information act.
 
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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
jorja nackard
1505 n. fourth street
flagstaff, AZ 86004
9285263030
MDR Report Key14745041
MDR Text Key294852963
Report Number2017233-2022-03022
Device Sequence Number1
Product Code FTL
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K963619
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Other
Reporter Occupation Non-Healthcare Professional
Type of Report Initial,Followup,Followup
Report Date 08/22/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/20/2022
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Was Device Available for Evaluation? No
Date Manufacturer Received08/22/2022
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: 06/20/2022 Patient Sequence Number: 1
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