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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
Device Problems Material Puncture/Hole (1504); Stretched (1601); Patient Device Interaction Problem (4001)
Patient Problems Unspecified Infection (1930); Necrosis Of Flap Tissue (1972); Respiratory Failure (2484)
Event Date 01/01/1991
Event Type  Injury  
Manufacturer Narrative
Additional device codes include: (b)(4). According to the instructions for use (ifu) for gore-tex® soft tissue patch, as with any surgical procedure, there are always risks of complications in surgical repair of soft tissue deficiencies, with or without mesh. Complications may include but are not limited to, infection,inflammation, adhesion, fistula formation, seroma formation, perforation, wound dehiscence, wound complications, pain, bowel obstruction, ileus, revision/re-intervention, fever and recurrence.
 
Event Description
The following publication was reviewed: reconstruction of chest wall defects. The publication reports one female patient who received a gore-tex® soft tissue patch experienced soft tissue flap necrosis and infection due to stretched suture holes in soft tissue patch due to tension from increasing physical activity. This was resolved by secondary omentum plasty and post operative mechanical ventilation therapy.
 
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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)
MPD APC B/P
p.o. box 1408
elkton MD 21922 1408
Manufacturer Contact
angela brown
1500 n. 4th street
9285263030
MDR Report Key9856870
MDR Text Key189032757
Report Number3003910212-2020-00033
Device Sequence Number1
Product Code FTL
Combination Product (y/n)N
Reporter Country CodeGM
PMA/PMN Number
K963619
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Reporter Occupation
Type of Report Initial,Followup,Followup
Report Date 07/02/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/19/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Event Location No Information
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: 03/19/2020 Patient Sequence Number: 1
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