MAUDE Adverse Event Report: W.L. GORE & ASSOCIATES GORE DUALMESH BIOMATERIAL MESH, SURGICAL, POLYMERIC

Model Number 1DLMC07

Device Problems Contamination (1120); Insufficient Information (3190); Patient Device Interaction Problem (4001)

Patient Problems Adhesion(s) (1695); Unspecified Infection (1930); No Code Available (3191)

Event Date 11/24/2012

Event Type  Injury  

Manufacturer Narrative

(b)(4). (b)(6). (b)(4) is being used for statements from the lawsuit complaint, which include "bowel twisted and adhered to the rest of the abdominal cavity," "suffered severe post-operative complications," "scarring under the mesh," "the patient suffered and continues to suffer both injuries and damages, including, but not limited to; past, present and future physical and mental pain and suffering; physical disability, and past, present, and future medical, hospital, rehabilitative, and pharmaceutical expenses, and other related damages. " "the patient will continue to sustain severe and debilitating injuries, economic loss, and other damages including, but not limited to, cost of medical care, rehabilitation, lost income, and pain and suffering. " impairing the patient quality of life and necessitating future medical treatment. The patient will require future medical care, assistance with activities of daily living, and an impaired earning capacity. " it should be noted that the gore® dualmesh® plus 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. ¿ the gore® dualmesh® plus biomaterial instructions for use also states: ¿strict aseptic techniques should be followed. If an infection develops, it should be treated aggressively. An unresolved infection may require removal of the material. ¿.

Event Description

It was reported to gore in a lawsuit complaint that the patient underwent hernia repair on or about (b)(6) 2006 using a gore® dualmesh® plus biomaterial (lot number 04429476). The lawsuit complaint states that "on or about (b)(6) 2011, the patient underwent a revision of the failed dualmesh by dr. (b)(6) at (b)(6) hospital. The operative reports notes there were a great deal of adhesions and ¿the bowel twisted and adhered to the rest of the abdominal cavity. ¿" the lawsuit complaint states the patient "¿suffered severe post-operative complications and required further surgical intervention. As noted in a (b)(6) 2012 operative report, the patient suffered from infected mesh and had to have the mesh removed which revealed substantial amounts of scarring under the mesh. " the lawsuit complaint states that the patient ¿¿suffered and continues to suffer both injuries and damages, including, but not limited to; past, present and future physical and mental pain and suffering; physical disability, and past, present, and future medical, hospital, rehabilitative, and pharmaceutical expenses, and other related damages. " the lawsuit complaint states "the patient will continue to sustain severe and debilitating injuries, economic loss, and other damages including, but not limited to, cost of medical care, rehabilitation, lost income, and pain and suffering. " the lawsuit complaint states ¿the dualmesh implanted caused the patient to suffer infections, numerous hospitalizations and surgeries, impairing her quality of life and necessitating future medical treatment. ¿ ¿the patient will require future medical care, assistance with activities of daily living, and an impaired earning capacity. " the lawsuit complaint states ¿the dualmesh caused the patient to suffer adhesions and infections, resulting in additional surgeries and removal of the dualmesh. ¿ additional information, including medical records, will be requested.

• Brand Name: GORE DUALMESH BIOMATERIAL
• Type of Device: MESH, 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 Key: 8332552
• MDR Text Key: 135938748
• Report Number: 2017233-2019-00080
• Device Sequence Number: 1
• Product Code: FTL
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K992189
• 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: 03/23/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/12/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No

Device Operator

• Device Expiration Date: 02/23/2011
• Device Model Number: 1DLMC07
• Device Catalogue Number: 1DLMC07
• Device Lot Number: 04229476
• 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 Manufactured: 02/24/2006
• 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: 02/12/2019 Patient Sequence Number: 1