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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
Catalog Number 1DLMC07
Device Problems No Apparent Adverse Event (3189); Insufficient Information (3190)
Patient Problems Adhesion(s) (1695); Nausea (1970); Pain (1994); Not Applicable (3189)
Event Date 08/31/2015
Event Type  Injury  
Manufacturer Narrative

(b)(4). Product identification records for the alleged gore device was not provided. Therefore, a review of the manufacturing records could not be performed. (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® plus 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 incisional hernia repair on (b)(6) 2006 whereby a gore dualmesh® plus biomaterial device was implanted. The complaint alleges that on (b)(6) 2015, the gore device was explanted. It was reported the patient alleges the following injuries: chronic abdominal pain, nausea, extensive dense abdominal adhesions, open abdominal wound, abscess, distended abdomen, small bowel resection, mesh infection, and mesh removal. 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 Key7640886
MDR Text Key112414837
Report Number2017233-2018-00340
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 OTHER CAREGIVERS
Type of Report Initial,Followup,Followup,Followup,Followup
Report Date 09/17/2020
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
Device EXPIRATION Date06/17/2010
Device Catalogue Number1DLMC07
Device LOT Number03757290
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
Date Device Manufactured06/18/2005
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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