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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 1DLMC06
Device Problems No Apparent Adverse Event (3189); Insufficient Information (3190)
Patient Problems Adhesion(s) (1695); Pain (1994); Obstruction/Occlusion (2422); Not Applicable (3189)
Event Date 05/26/2011
Event Type  Injury  
Manufacturer Narrative
(b)(4). (b)(6). It should be noted that the gore dualmesh® biomaterial instructions for use includes warnings and addresses the following adverse reactions among others: ¿strict aseptic techniques should be followed. If an infection develops, it should be treated aggressively. An unresolved infection may require removal of the material. ¿ ¿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 laparoscopic ventral hernia repair on (b)(6) 2006 whereby a dualmesh® biomaterial device was implanted. The complaint alleges that on (b)(6) 2011, an additional procedure was performed whereby explant of the gore device was performed. It was reported the patient alleges the following injuries: abdominal pain, adhesions, small bowel obstruction, small bowel perforation, small bowel resection, intraabdominal sepsis, mesh removal. Additional event specific information was not provided.
 
Manufacturer Narrative
Updated result code. Conclusion code remains unchanged.
 
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Brand NameGORE DUALMESH BIOMATERIAL
Type of DeviceMESH, SURGICAL, POLYMERIC
Manufacturer (Section D)
W.L. GORE & ASSOCIATES
flagstaff AZ
MDR Report Key7843547
MDR Text Key119109114
Report Number2017233-2018-00540
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 11/13/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/04/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date03/24/2009
Device Model Number1DLMC06
Device Catalogue Number1DLMC06
Device Lot Number02987092
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: 09/04/2018 Patient Sequence Number: 1
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