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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 1420030010
Device Problem Insufficient Information (3190)
Patient Problem Unspecified Infection (1930)
Event Date 08/01/2019
Event Type  Injury  
Event Description
It was reported to gore that the patient underwent laparoscopic parastomal hernia repair on (b)(6) 2017 whereby a gore-tex® soft tissue patch was implanted. The complaint alleges that on (b)(6) 2019, an additional procedure occurred whereby the gore device was explanted. It was reported the patient alleges the following injuries: hernia recurrence, soft tissue abdominal wall excision-mesh with fibrinopurulent debris, infected mesh, infected prosthetic mesh of abdominal wall, and infection. Additional event specific information was not provided.
 
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. ".
 
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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)
MPD APC B/P
p.o. box 1408
elkton MD 21922 1408
Manufacturer Contact
vanessa rodriguez
1505 n. fourth street
flagstaff, AZ 86004
9285263030
MDR Report Key13619985
MDR Text Key286256338
Report Number3003910212-2022-01339
Device Sequence Number1
Product Code FTL
UDI-Device Identifier00733132600618
UDI-Public00733132600618
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 04/14/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/28/2022
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date02/28/2019
Device Model Number1420030010
Device Catalogue Number1420030010
Was Device Available for Evaluation? No
Date Manufacturer Received04/07/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured03/31/2014
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: 02/28/2022 Patient Sequence Number: 1
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