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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
Model Number 1DLMC03
Device Problem Insufficient Information (3190)
Patient Problem Hernia (2240)
Event Date 11/03/2010
Event Type  Injury  
Manufacturer Narrative
It should be noted that the gore® dualmesh® biomaterial instructions for use addresses the following adverse reactions among others: ¿possible adverse reactions with the use of any tissue deficiency prosthesis may include, but are not limited to, contamination, infection, inflammation, adhesion, fistula formation, seroma formation, hematoma, and recurrence.
 
Event Description
It was reported to gore that the patient underwent open incisional hernia repair on (b)(6) 2006 whereby a gore® dualmesh® biomaterial was implanted. The complaint alleges that on (b)(6) 2010, an additional procedure occurred whereby the gore device was explanted. It was reported the patient alleges the following injuries: adhesions, meshoma, migration, pain. Additional event specific information was not provided. Initial review of the medical records indicate a reportable hernia recurrence.
 
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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)
MEDICAL WOODY MOUNTAIN B/P
3750 w. kiltie lane
flagstaff AZ 86005
Manufacturer Contact
jorja nackard
1505 n. fourth street
flagstaff, AZ 86004
9285263030
MDR Report Key14526806
MDR Text Key293367568
Report Number2017233-2022-02969
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 Other
Reporter Occupation Non-Healthcare Professional
Type of Report Initial,Followup
Report Date 07/14/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/27/2022
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date10/26/2010
Device Model Number1DLMC03
Device Catalogue Number1DLMC03
Was Device Available for Evaluation? No
Date Manufacturer Received07/07/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured10/27/2005
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: 05/27/2022 Patient Sequence Number: 1
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