MAUDE Adverse Event Report: W.L. GORE & ASSOCIATES UNKNOWN

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.

• Brand Name: UNKNOWN
• 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 Key: 7843370
• MDR Text Key: 119151227
• Report Number: 2017233-2018-00539
• Device Sequence Number: 1
• Product Code: FTL
• Combination Product (Y/N): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer

Reporter Occupation

• 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 Received: 09/04/2018
• 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?

• 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