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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
Model Number 1DLM06
Device Problem Insufficient Information (3190)
Patient Problems Abscess (1690); Post Operative Wound Infection (2446); No Code Available (3191)
Event Date 08/15/2014
Event Type  Injury  
Manufacturer Narrative

(b)(4). Product identification records for the alleged gore device was not provided. Therefore, a review of the manufacturing records could not be performed. (b)(6). It should be noted that the gore-tex® soft tissue patch 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.

 
Event Description

It was reported to gore that the patient underwent laparoscopic incisional hernia repair on [date] whereby a [device brand] was implanted. The complaint alleges that on (b)(6) 2014, an additional procedure occurred whereby the gore device was explanted. It was reported the patient alleges the following injuries: drainage of wound infection, drainage of wound abscess, removal of mesh requiring an additional surgery. Additional event specific information was not provided.

 
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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)
MEDICAL WOODY MOUNTAIN B/P
3750 w. kiltie lane
flagstaff AZ 86005
Manufacturer Contact
sara collum
1500 n. 4th street
9285263030
MDR Report Key9148046
MDR Text Key162316476
Report Number2017233-2019-00977
Device Sequence Number1
Product Code FTL
Combination Product (Y/N)N
Reporter Country CodeUS
PMA/PMN NumberK992189
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Reporter Occupation
Type of Report Initial,Followup
Report Date 10/02/2019
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received10/02/2019
Is This An Adverse Event Report? Yes
Device Operator HEALTH PROFESSIONAL
Device MODEL Number1DLM06
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
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: 10/02/2019 Patient Sequence Number: 1
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