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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 Contamination (1120); Adverse Event Without Identified Device or Use Problem (2993); Insufficient Information (3190)
Patient Problems Unspecified Infection (1930); Pain (1994); Infection, Pyrogenic (2246); No Code Available (3191)
Event Date 01/13/2017
Event Type  Injury  
Manufacturer Narrative
Added medical history. (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: ¿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. ¿ the gore dualmesh® biomaterial instructions for use also states: ¿strict aseptic techniques should be followed. If an infection develops, it should be treated aggressively. An unresolved infection may require removal of the material. ¿.
 
Event Description
It was reported to gore that the patient underwent laparoscopic ventral and umbilical hernia repair on (b)(6) 2009 whereby a gore dualmesh® biomaterial was implanted. The complaint alleges that on (b)(6) 2017, an additional procedure occurred whereby the gore device was explanted. It was reported the patient alleges the following injuries: additional surgery, mesh removal, infection, mesh failure, and pain. Additional event specific information was not provided.
 
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Brand NameGORE DUALMESH 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
kathy titus
1500 n. 4th street
flagstaff, AZ 
9285263030
MDR Report Key8217768
MDR Text Key132089387
Report Number3003910212-2019-00005
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
Reporter Occupation
Type of Report Initial,Followup,Followup,Followup,Followup
Report Date 03/17/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/04/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date11/04/2012
Device Model Number1DLMC06
Device Catalogue Number1DLMC06
Device Lot Number05524743
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 Manufactured11/06/2007
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: 01/04/2019 Patient Sequence Number: 1
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