• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

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

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

W.L. GORE & ASSOCIATES GORE DUALMESH BIOMATERIAL MESH, SURGICAL, POLYMERIC Back to Search Results
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.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

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 Key8332552
MDR Text Key135938748
Report Number2017233-2019-00080
Device Sequence Number1
Product Code FTL
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K992189
Number of Events Reported1
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 Received02/12/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date02/23/2011
Device Model Number1DLMC07
Device Catalogue Number1DLMC07
Device Lot Number04229476
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 Manufactured02/24/2006
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
-
-