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U.S. Department of Health and Human Services

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

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W. L. GORE & ASSOCIATES, INC. GORE® DUALMESH® PLUS BIOMATERIAL MESH, SURGICAL, POLYMERIC Back to Search Results
Device Problems Break (1069); Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Erosion (1750); Hematoma (1884)
Event Date 04/27/2020
Event Type  Injury  
Manufacturer Narrative
No patient specific details have been provided. Therefore, the patient initials reflect the w. L. Gore internal case number. No patient specific information regarding the reported events and interventions was provided in the article. The mean age among the patients in the kh group was reported to 69 years where the majority of the patents are male. The date of incident is unknown. Therefore, the online publication date of the literature article is used as date of incident. The plus antimicrobial product coating contains silver carbonate [approximately 800 micrograms per cubic centimeter of product (g/cm3)], and chlorhexidine diacetate [approximately 1600 micrograms per cubic centimeter of product (g/cm3)]. Email of the initial reporter: (b)(6). Review of the manufacturing records could not be performed as a valid lot number was not provided. Engineering evaluation could not be performed as the device was not returned. (b)(4). Literature citation: bertoglio, c. , morini, l. , maspero, m. , zironda, a. , alampi, b. , mazzola, m. , magistro, c. And ferrari, g. (2021). ¿from keyhole to sandwich: change in laparoscopic repair of parastomal hernias at a single centre¿, surgical endoscopy, 35, pp. 1863¿1871.
 
Event Description
The following literature article was reviewed: bertoglio, c. , morini, l. , maspero, m. , zironda, a. , alampi, b. , mazzola, m. , magistro, c. And ferrari, g. (2021). ¿from keyhole to sandwich: change in laparoscopic repair of parastomal hernias at a single centre¿, surgical endoscopy, 35, pp. 1863¿1871. This study describes postoperative outcomes for different parastomal hernia (psh) repair techniques. Between january 2004 and december 2018, a consecutive series of 32 patients presenting with psh were treated laparoscopically at niguarda general hospital, milan, italy. Out of these, 19 patients were treated with keyhole (kh) repair using gore® dualmesh® plus biomaterial during january 2004 and october 2014. The following serious incidents were reported by the article: one patients had short-term (30 days) complication of parietal hematoma treated with embolization of the epigastric artery, one patient had long-term (1 year postoperative) complication with bowel perforation of the stoma loop following mesh erosion 3 years after kh repair, which required resection of the stoma loop, mesh removal and fashioning of a new stoma.
 
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Brand NameGORE® DUALMESH® PLUS 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
ida simson
1505 n. fourth street
flagstaff, AZ 86004
9285263030
MDR Report Key12922701
MDR Text Key281653886
Report Number3003910212-2021-01317
Device Sequence Number1
Product Code FTL
Combination Product (y/n)Y
Reporter Country CodeIT
PMA/PMN Number
K063435
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Literature
Reporter Occupation
Type of Report Initial,Followup,Followup
Report Date 03/02/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/03/2021
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
Date Manufacturer Received02/07/2022
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: 12/03/2021 Patient Sequence Number: 1
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