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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
Model Number 1DLMC03
Device Problems Adverse Event Without Identified Device or Use Problem (2993); Insufficient Information (3190); Loosening of Implant Not Related to Bone-Ingrowth (4002)
Patient Problems Pain (1994); Hernia (2240); No Information (3190)
Event Type  Injury  
Manufacturer Narrative
The initial reporter's complete address is (b)(6). It should be noted that the gore dualmesh® biomaterial instructions for use includes warnings and 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 a patient asserts a complaint arising from the implantation of a gore dualmesh® biomaterial device based on an unspecified alleged injury and/or alleged product deficiency. As no specific information was provided as to the patient¿s complaint about the gore dualmesh® biomaterial device, this event is being documented based on a general allegation of an unknown product deficiency and/or alleged injury.
 
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Brand NameGORE DUALMESH BIOMATERIAL
Type of DeviceMESH, SURGICAL, POLYMERIC
Manufacturer (Section D)
W.L. GORE & ASSOCIATES
flagstaff AZ
MDR Report Key7948414
MDR Text Key123125433
Report Number3003910212-2018-00091
Device Sequence Number1
Product Code FTL
Combination Product (y/n)N
PMA/PMN Number
K992189
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Type of Report Initial,Followup,Followup,Followup,Followup
Report Date 11/12/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/09/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date08/10/2014
Device Model Number1DLMC03
Device Catalogue Number1DLMC03
Device Lot Number6964412
Was Device Available for Evaluation? No
Was the Report Sent to FDA? No
Event Location No Information
Is This a Reprocessed and Reused Single-Use Device? No

Patient Treatment Data
Date Received: 10/09/2018 Patient Sequence Number: 1
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