• 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, INC. 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, INC. GORE DUALMESH BIOMATERIAL MESH, SURGICAL, POLYMERIC Back to Search Results
Device Problem Use of Device Problem (1670)
Patient Problem Wound Dehiscence (1154)
Event Date 11/22/2018
Event Type  Injury  
Manufacturer Narrative
Journal article: international journal of surgery case reports 53 (2018) 381¿385 https://doi. Org/10. 1016/j. Ijscr. 2018. 11. 028 2210-2612/© 2018 the authors. Published by elsevier ltd on behalf of ijs publishing group ltd. This is an open access article under the cc by license (http://creativecommons. Org/licenses/by/4. 0/). Multiple attempts have been made to obtain additional information. As no additional information has been received from the corresponding author, this file will be closed. Per the instructions for use (ifu) for the gore® dualmesh® biomaterial usage: do not fix this product with the textured surface facing the organ side. When fixed with the textured surface facing the organ side, adhesion or seroma formation may develop. Operating instructions and method of use, etc. This product shall be fixed with the smooth side facing toward the organs, after being trimmed to a proper size and shape. Individual medical decisions, if inconsistent and/or non-conforming to the device manufacturer¿s recommendations, ifu, or recognized best practices, may result in or contribute to an adverse event. There is insufficient information available for gore to reasonably draw conclusions related to aspects of the event. Insufficient information may include limited or missing relevant medical records, involvement of multiple implanted devices (including non-gore devices) in the field of treatment, patient non-compliance, and/or a general lack of available detail or specificity related to an adverse event and/or device. ".
 
Event Description
The literature article: ¿mesh trimming and suture reconstruction for wound dehiscence after huge abdominal intercostal hernia repair: a case report¿ published by yuta takeuchi, m. D. Was reviewed. The article was published online november 22, 2018. The article reports a (b)(6)-year-old man with an incisional hernia in the left flank from just below the eight intercostal space to the transverse umbilical region 6 months after thoracoabdominal aortic aneurysm surgery. At post operative day 26, we observed mesh exposure due to wound dehiscence. Mesh trimming and suture reconstruction for wound dehiscence was performed because there were no signs of wound infection. The postoperative course was uneventful including infection and dehiscence. The patient has been well without recurrence for 14 months since last operation. On postoperative day 26, we detected that a 3 × 7 cm mesh was exposed due to wound dehiscence without infection. The patient was placed on the right semi-lateral decubitus position under general anesthesia. A 20-cm long incision was made over the hernia along the previous wound. The hernia sac was identified and opened. There was no adhesion between the hernia sac and intra-abdominal contents. We tried to secure a space to place the mesh (35 25 cm in size) in the extraperitoneal space. The mesh was expanded × polytetrafluoroethylene: gore® dualmesh® patch. The article reports 1 wound dehiscence and a partial mesh explant.
 
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, INC.
1505 n. fourth street
flagstaff AZ 86004
Manufacturer (Section G)
MPD APC B/P
p.o. box 1408
elkton MD 21922 1408
Manufacturer Contact
1505 n. fourth street
flagstaff, AZ 86004
9285263030
MDR Report Key10834179
MDR Text Key216118679
Report Number3003910212-2020-01135
Device Sequence Number1
Product Code FTL
Combination Product (y/n)N
Reporter Country CodeJA
PMA/PMN Number
K992189
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type literature
Reporter Occupation
Type of Report Initial
Report Date 11/12/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/13/2020
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? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received10/16/2020
Was Device Evaluated by Manufacturer? No Answer Provided
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device?
Type of Device Usage Initial

Patient Treatment Data
Date Received: 11/13/2020 Patient Sequence Number: 1
-
-