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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 1DLMCP203
Device Problems Contamination (1120); Insufficient Information (3190); Patient Device Interaction Problem (4001)
Patient Problems Abscess (1690); Unspecified Infection (1930); Discharge (2225)
Event Date 03/03/2006
Event Type  Injury  
Manufacturer Narrative
(b)(6). It should be noted that the gore® dualmesh® plus biomaterial instructions for use 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 addresses the following warning 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. ¿.
 
Event Description
It was reported to gore that the patient underwent open incisional hernia repair on (b)(6) 2006, whereby a gore® dualmesh® plus biomaterial was implanted. The complaint alleges that on (b)(6) 2006, an additional procedure occurred whereby the gore device was explanted. It was reported the patient alleges the following injuries: infection of mesh, removal of mesh, abdominal wall abscess and drainage . Additional event specific information and medical records have been requested.
 
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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)
MEDICAL WOODY MOUNTAIN B/P
3750 w. kiltie lane
flagstaff AZ 86005
Manufacturer Contact
damon jackson
1500 n. 4th street
9285263030
MDR Report Key8375003
MDR Text Key137294803
Report Number2017233-2019-00109
Device Sequence Number1
Product Code FTL
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
Type of Report Initial,Followup,Followup,Followup,Followup
Report Date 03/22/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/27/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date07/09/2006
Device Model Number1DLMCP203
Device Catalogue Number1DLMCP203
Device Lot Number03139583
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 Manufactured07/09/2004
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: 02/27/2019 Patient Sequence Number: 1
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