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U.S. Department of Health and Human Services

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

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W.L. GORE & ASSOCIATES GORE DUALMESH PLUS BIOMATERIAL MESH, SURGICAL, POLYMERIC Back to Search Results
Model Number 1DLMCP08
Device Problems Use of Device Problem (1670); Microbial Contamination of Device (2303); Insufficient Information (3190)
Patient Problems Adhesion(s) (1695); Unspecified Infection (1930); Pain (1994); Infection, Pyrogenic (2246)
Event Date 05/08/2014
Event Type  Injury  
Manufacturer Narrative
(b)(4) (b)(6). It should be noted that the gore dualmesh® plus biomaterial instructions for use includes warnings and addresses the following adverse reactions among others: ¿strict aseptic techniques should be followed. If an infection develops, it should be treated aggressively. An unresolved infection may require removal of the material. ¿ ¿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. ¿.
 
Event Description
It was reported to gore that the patient underwent laparoscopic incisional hernia repair on (b)(6) 2013 whereby a gore dualmesh® plus biomaterial was implanted. The complaint alleges that on (b)(6) 2014, an additional procedure was performed whereby explant of the gore device was performed. It was reported the patient alleges the following injuries: abdominal pain, adhesions, infected mesh, abdominal abscess, drainage of wound, wound vac, and revision surgery. Additional event specific information was not provided.
 
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Brand NameGORE DUALMESH PLUS 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
kathy titus
1500 n. 4th street
flagstaff, AZ 
9285263030
MDR Report Key7838292
MDR Text Key118937845
Report Number3003910212-2018-00080
Device Sequence Number1
Product Code FTL
UDI-Device Identifier00733132601158
UDI-Public00733132601158
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K063435
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Reporter Occupation Non-Healthcare Professional
Type of Report Initial,Followup,Followup,Followup
Report Date 10/26/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/31/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date09/30/2015
Device Model Number1DLMCP08
Device Catalogue Number1DLMCP08
Device Lot Number10960269
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 Manufactured10/10/2012
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: 08/31/2018 Patient Sequence Number: 1
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