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U.S. Department of Health and Human Services

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

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W.L. GORE & ASSOCIATES GORE DUALMESH® PLUS BIOMATERIAL MESH, SURGICAL, POLYMERIC Back to Search Results
Catalog Number 1DLMCP03
Device Problem Insufficient Information (3190)
Patient Problems Post Operative Wound Infection (2446); No Code Available (3191)
Event Date 04/01/2014
Event Type  Injury  
Manufacturer Narrative

(b)(6). (b)(4). It should be noted that the gore® dualmesh® plus 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 laparoscopic converted to open incisional hernia repair on (b)(6) 2010 whereby a gore® dualmesh® plus biomaterial was implanted. The complaint alleges that on (b)(6) 2014, an additional procedure occurred whereby the gore device was explanted. It was reported the patient alleges the following injuries: mesh contracture, mesh removal, post operative wound infection with non-healing wound, i&d with vac placement [(b)(6) 2014]. 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
flagstaff AZ
Manufacturer (Section G)
MPD APC B/P
p.o. box 1408
elkton MD 21922 1408
Manufacturer Contact
katheryn fox
9285263030
MDR Report Key9196167
MDR Text Key174626954
Report Number3003910212-2019-00410
Device Sequence Number1
Product Code FTL
Combination Product (Y/N)N
Reporter Country CodeUS
PMA/PMN NumberK063435
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Reporter Occupation
Type of Report Initial,Followup,Followup
Report Date 11/13/2019
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received10/16/2019
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator HEALTH PROFESSIONAL
Device EXPIRATION Date08/31/2012
Device Catalogue Number1DLMCP03
Device LOT Number7285757
Was Device Available For Evaluation? No
Is The Reporter A Health Professional?
Was the Report Sent to FDA? No
Event Location No Information
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured09/22/2009
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: 10/16/2019 Patient Sequence Number: 1
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