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U.S. Department of Health and Human Services

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

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W. L. GORE & ASSOCIATES, INC. GORE® DUALMESH® PLUS BIOMATERIAL MESH, SURGICAL, POLYMERIC Back to Search Results
Model Number 1DLMCP04
Device Problem Insufficient Information (3190)
Patient Problem Unspecified Infection (1930)
Event Date 10/10/2011
Event Type  Injury  
Event Description
It was reported to gore that the patient underwent incisional hernia repair on (b)(6) 2011 whereby a gore® dualmesh® plus biomaterial was implanted. The complaint alleges that on (b)(6) 2011, an additional procedure occurred whereby the gore device was explanted. It was reported the patient alleges the following injuries: mesh removal, infection, abscess, seroma, pain and suffering. Additional event specific information was not provided.
 
Event Description
It was reported to gore that the patient underwent incisional hernia repair on (b)(6) 2011 whereby a gore® dualmesh® plus biomaterial was implanted. The complaint alleges that on (b)(6) 2011, an additional procedure occurred whereby the gore device was explanted. It was reported the patient alleges the following injuries: mesh removal, infection, abscess, seroma, pain and suffering. Additional event specific information was not provided.
 
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Brand NameGORE® DUALMESH® PLUS 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
jorja nackard
1505 n. fourth street
flagstaff, AZ 86004
9285263030
MDR Report Key13319105
MDR Text Key286076661
Report Number3003910212-2022-01328
Device Sequence Number1
Product Code FTL
Combination Product (y/n)Y
Reporter Country CodeUS
PMA/PMN Number
K063435
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
Report Date 03/25/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/21/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? No
Device Expiration Date03/31/2012
Device Model Number1DLMCP04
Device Catalogue Number1DLMCP04
Was Device Available for Evaluation? No
Date Manufacturer Received03/23/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured04/27/2009
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: 01/21/2022 Patient Sequence Number: 1
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