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W.L. GORE & ASSOCIATES UNKNOWN Back to Search Results
Device Problems No Apparent Adverse Event (3189); Insufficient Information (3190)
Patient Problems Pain (1994); Hernia (2240); Obstruction/Occlusion (2422); Not Applicable (3189)
Event Date 06/18/2002
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. The initial reporter's complete address is ketterer (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 incisional hernia repair on an unknown date in (b)(6) 2000 whereby an alleged "gore-tex" device was implanted. It was reported to gore that the patient underwent open ventral repair on (b)(6) 2002 whereby an dualmesh® biomaterial was implanted. The complaint alleges that on (b)(6) 2002 an additional procedure was performed whereby explant of the gore device was performed. The complaint alleges that on (b)(6) 2013 an additional procedure was performed whereby explant of the gore device was performed. It was reported the patient alleges the following injuries: abdominal pain, small bowel obstruction, small bowel resection, hernia recurrence, mesh removal. Additional event specific information was not provided.
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Manufacturer (Section D)
flagstaff AZ
Manufacturer (Section G)
3750 w. kiltie lane
flagstaff AZ 86005
Manufacturer Contact
kathy titus
1500 n. 4th street
flagstaff, AZ 
MDR Report Key7843370
MDR Text Key119151227
Report Number2017233-2018-00539
Device Sequence Number1
Product Code FTL
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Reporter Occupation Non-Healthcare Professional
Type of Report Initial,Followup,Followup,Followup,Followup
Report Date 11/13/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/04/2018
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?
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: 09/04/2018 Patient Sequence Number: 1