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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: W.L. GORE & ASSOCIATES GORE DUALMESH BIOMATERIAL MESH, SURGICAL, POLYMERIC

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W.L. GORE & ASSOCIATES GORE DUALMESH BIOMATERIAL MESH, SURGICAL, POLYMERIC Back to Search Results
Device Problems Contamination (1120); Adverse Event Without Identified Device or Use Problem (2993); Insufficient Information (3190)
Patient Problems Unspecified Infection (1930); Seroma (2069)
Event Date 06/08/2002
Event Type  Injury  
Manufacturer Narrative
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 publication was reviewed: the use of three different mesh materials in the treatment of abdominal wall defects. The publication reports between 1996 and 2000, 56 patients underwent surgery for the treatment of large abdominal wall defects with the use of synthetic prosthetic materials. The article reports in twenty-three patients the surgeon used gore® dualmesh® biomaterial. The article reported the radius of the mesh was about 4-5 cm larger than the defects. The articles reports in the e-ptfe group one obese patient (4. 34%) developed a persistent seroma that was infected after repeated aspirations. The article reported the infection led to mesh removal and recurrence of the hernia 3 months later.
 
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Brand NameGORE DUALMESH BIOMATERIAL
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 Key9649233
MDR Text Key185783502
Report Number3003910212-2020-00011
Device Sequence Number1
Product Code FTL
Combination Product (y/n)N
Reporter Country CodeGR
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 09/23/2020
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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