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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 No Apparent Adverse Event (3189); Insufficient Information (3190)
Patient Problems Adhesion(s) (1695); Pain (1994); Hernia (2240); Not Applicable (3189)
Event Date 05/13/2016
Event Type  Injury  
Manufacturer Narrative

Separate medwatch reports are being submitted for the alleged gore devices reportedly implanted on (b)(6). (b)(6). (b)(4). 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 the patient underwent laparoscopic ventral hernia repair on (b)(6) 2005 whereby an alleged gore dualmesh® biomaterial was implanted. It was also reported that on (b)(6) 2005 and (b)(6) 2006 the patient underwent laparoscopic ventral hernia repairs whereby an alleged gore dualmesh® biomaterial was implanted. The complaint alleges that on (b)(6) 2016 an additional procedure was performed whereby explant of the gore devices was performed. It was reported the patient alleges the following injuries: adhesions to abdominal wall and small bowel, hernia recurrences, persistent pelvic and abdominal pain, additional surgeries for revision/removal of mesh. Additional event specific information and medical records have been requested.

 
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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 Key7641564
MDR Text Key112453857
Report Number2017233-2018-00355
Device Sequence Number1
Product Code FTL
Combination Product (Y/N)N
Reporter Country CodeUS
PMA/PMN NumberK992189
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 08/27/2020
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 HEALTH PROFESSIONAL
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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