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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: W.L. GORE & ASSOCIATES GORE DUALMESH PLUS BIOMATERIAL MULTIPURPOSE SURGICAL MESH, SYNTHETIC POLYMER, NON-BIOABSORBABLE, ANTIMICROBIAL

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W.L. GORE & ASSOCIATES GORE DUALMESH PLUS BIOMATERIAL MULTIPURPOSE SURGICAL MESH, SYNTHETIC POLYMER, NON-BIOABSORBABLE, ANTIMICROBIAL Back to Search Results
Device Problems Contamination (1120); Adverse Event Without Identified Device or Use Problem (2993); Insufficient Information (3190)
Patient Problem Unspecified Infection (1930)
Event Date 07/13/2005
Event Type  Injury  
Manufacturer Narrative
Patient information was requested, but not provided. Additionally, event information such as item/lot number, implant date, date of explant, patient medical history were requested, however no information has been received. According to the instructions for use (ifu) for gore® dualmesh® biomaterial 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 literature article was reviewed, "laparoscopic ventral hernia repair with the gore-tex dualmesh: long-term results and review of the literature. " the article reports 146 patients had a laparoscopic ventral hernia repair using intraperitoneal gore® dualmesh® biomaterial with a 3-5 cm mesh overlap secured with a combination of non absorbable sutures and staples. It was reported that one patient developed an infection that required removal of the device.
 
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Brand NameGORE DUALMESH PLUS BIOMATERIAL
Type of DeviceMULTIPURPOSE SURGICAL MESH, SYNTHETIC POLYMER, NON-BIOABSORBABLE, ANTIMICROBIAL
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 Key9648976
MDR Text Key189996765
Report Number3003910212-2020-00007
Device Sequence Number1
Product Code FTL
Combination Product (y/n)N
Reporter Country CodeFR
PMA/PMN Number
K992189
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Reporter Occupation
Type of Report Initial,Followup
Report Date 07/02/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/30/2020
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: 01/30/2020 Patient Sequence Number: 1
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