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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 1DLMC07
Device Problem Insufficient Information (3190)
Patient Problem Hernia (2240)
Event Date 04/05/2018
Event Type  Injury  
Event Description
It was reported to gore that the patient underwent open ventral hernia repair on (b)(6)2007 whereby a gore® dualmesh® biomaterial was implanted. The complaint alleges that on (b)(6) 2018, an additional procedure occurred whereby the gore device was explanted. It was reported the patient alleges the following injuries: adhesions, hernia recurrence, and removal. Additional event specific information was not provided.
 
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. ".
 
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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
vanessa rodriguez
1505 n. fourth street
flagstaff, AZ 86004
9285263030
MDR Report Key14526795
MDR Text Key293353315
Report Number2017233-2022-02971
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
Report Date 05/27/2022
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 Date12/26/2010
Device Model Number1DLMC07
Device Catalogue Number1DLMC07
Was Device Available for Evaluation? No
Date Manufacturer Received05/26/2022
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured12/27/2005
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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