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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
Device Problems Contamination (1120); Improper or Incorrect Procedure or Method (2017); Insufficient Information (3190)
Patient Problems Adhesion(s) (1695); Unspecified Infection (1930); Pain (1994); Hernia (2240)
Event Date 01/10/2007
Event Type  Injury  
Manufacturer Narrative
(b)(4). (b)(6). Product identification records for the alleged gore device was not provided. Therefore, a review of the manufacturing records could not be performed. 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 open incisional hernia repair on (b)(6) 2001 whereby an alleged gore device was implanted. The complaint alleges that on (b)(6) 2002, the patient again underwent open incisional hernia repair whereby a gore dualmesh® plus biomaterial was implanted. It was reported that an additional procedure was performed on (b)(6) 2007 whereby the gore devices were explanted. It was reported the patient alleges the following injuries: abdominal pain and discomfort, hernia recurrence, extensive adhesions, mesh infection, and mesh removal. 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)
MEDICAL WOODY MOUNTAIN B/P
3750 w. kiltie lane
flagstaff AZ 86005
Manufacturer Contact
kathy titus
1500 n. 4th street
flagstaff, AZ 
9285263030
MDR Report Key7641004
MDR Text Key112424175
Report Number2017233-2018-00343
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 Other Caregivers
Type of Report Initial,Followup,Followup,Followup,Followup
Report Date 10/15/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/27/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Event Location No Information
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
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: 06/27/2018 Patient Sequence Number: 1
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