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U.S. Department of Health and Human Services

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

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W. L. GORE & ASSOCIATES, INC. GORE® DUALMESH® BIOMATERIAL MESH, SURGICAL, POLYMERIC Back to Search Results
Device Problem Insufficient Information (3190)
Patient Problem Unspecified Infection (1930)
Event Date 03/17/2022
Event Type  Injury  
Event Description
It was reported to gore that during the sages congress a presenting physician dr. Garth jacobson stated he had to explant a gore® dualmesh® biomaterial device due to infection. From the presentation the device appeared to be oriented correctly, textured side to abdominal wall. The device was not used in a temporary bridging application. The device removal was due to infection and not incidental to another procedure. It is unknown if the device is available for return at this time.
 
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Brand NameGORE® DUALMESH® BIOMATERIAL
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
megan reigh
1505 n. fourth street
flagstaff, AZ 86004
9285263030
MDR Report Key14189909
MDR Text Key290549357
Report Number3003910212-2022-01349
Device Sequence Number1
Product Code FTL
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K992189
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Company Representative
Reporter Occupation
Type of Report Initial
Report Date 04/19/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/22/2022
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
Date Manufacturer Received03/29/2022
Was Device Evaluated by Manufacturer? No Answer Provided
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: 04/22/2022 Patient Sequence Number: 1
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