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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: W.L. GORE & ASSOCIATES GORE DUALMESH BIOMATERIAL

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W.L. GORE & ASSOCIATES GORE DUALMESH BIOMATERIAL Back to Search Results
Catalog Number 1DLMC03
Device Problems No Apparent Adverse Event (3189); Insufficient Information (3190)
Patient Problems Adhesion(s) (1695); Pain (1994); Not Applicable (3189)
Event Date 09/21/2017
Event Type  Injury  
Manufacturer Narrative

Product identification records for the alleged gore device was not provided. Therefore, a review of the manufacturing records could not be performed. (b)(6). It should be noted that although the brand name and lot# of a gore device has not been provided, the instructions for use for the vast majority of gore¿s eptfe patch products that are indicated for the reconstruction of soft tissue deficiencies include the following warnings among others: ¿possible 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 umbilical hernia repair on (b)(6) 2007, whereby an alleged ¿gore-tex¿ device was implanted. The complaint alleges that on (b)(6) 2017, an additional procedure was performed whereby explant of the gore device was performed. It was reported the patient alleges the following injuries: additional surgeries, abdominal pain, mesh removal, extensive adhesions. Additional event specific information was not provided.

 
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Brand NameGORE DUALMESH BIOMATERIAL
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 Key8063919
MDR Text Key126936092
Report Number2017233-2018-00677
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
Type of Report Initial,Followup,Followup,Followup,Followup
Report Date 11/19/2020
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received11/13/2018
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator HEALTH PROFESSIONAL
Device EXPIRATION Date10/23/2011
Device Catalogue Number1DLMC03
Device LOT Number04682391
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 Manufactured10/24/2006
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: 11/13/2018 Patient Sequence Number: 1
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