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U.S. Department of Health and Human Services

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

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W.L. GORE & ASSOCIATES GORE DUALMESH® BIOMATERIAL MESH, SURGICAL, POLYMERIC Back to Search Results
Device Problems Patient-Device Incompatibility (2682); Adverse Event Without Identified Device or Use Problem (2993); Insufficient Information (3190)
Patient Problems Bacterial Infection (1735); Seroma (2069); Post Operative Wound Infection (2446)
Event Date 02/02/2018
Event Type  Injury  
Manufacturer Narrative

Despite multiple requests for information, patient id, weight and health history were not received. Additionally, the device lot number and implant/explant dates were not received. Per the article, 108 patients were women and 48 were men. The median age was 59. 5 (ranging from 19 to 83) years, therefore patient information is estimated. The date of the article is used as the event date. Adverse reactions in the instructions for use (ifu) for gore® dualmesh® biomaterial state the following: as with any surgical procedure, there are always risks of complications in surgical repair of soft tissue deficiencies, with or without mesh. Complications may include but are not limited to, infection, inflammation, adhesion, fistula formation, seroma formation, perforation, wound dehiscence, would complications, pain, bowel obstruction, ileus, revision/re-intervention, fever and recurrence.

 
Event Description

The following publication titled "the results of expanded polytetrafluoroethylene mesh repair in difficult abdominal wall defects" from the asian journal of surgery was reviewed. The publication reports a study of abdominal wall defects of various etiopathologies at dokuz eylul university hospital between october 1997 and june 2011. The study included 156 adult patients who underwent difficult abdominal wall reconstruction (awr) with e-ptfe mesh for incisional hernia and ventral hernias, and created abdominal wall defects (awds) of various etiopathologies. Among the data it was noted that a patient developed a seroma after being implanted with gore® dualmesh® biomaterial. An additional surgical procedure was reportedly necessary to remove the device.

 
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Brand NameGORE DUALMESH® BIOMATERIAL
Type of DeviceMESH, SURGICAL, POLYMERIC
Manufacturer (Section D)
W.L. GORE & ASSOCIATES
flagstaff AZ
Manufacturer (Section G)
MPD APC B/P
p.o. box 1408
elkton MD 21922 1408
Manufacturer Contact
cheryl hawke
1500 n. 4th street
9285263030
MDR Report Key8955885
MDR Text Key161178510
Report Number3003910212-2019-00291
Device Sequence Number1
Product Code FTL
Combination Product (Y/N)N
Reporter Country CodeTU
PMA/PMN NumberK992189
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Reporter Occupation OTHER HEALTH CARE PROFESSIONAL
Type of Report Initial,Followup,Followup
Report Date 12/16/2019
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received09/03/2019
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? Yes
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: 09/03/2019 Patient Sequence Number: 1
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