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U.S. Department of Health and Human Services

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

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W.L. GORE & ASSOCIATES GORE® SYNECOR INTRAPERITONEAL BIOMATERIAL MESH, SURGICAL, POLYMERIC Back to Search Results
Model Number GKFV1520
Device Problem Insufficient Information (3190)
Patient Problem Unspecified Infection (1930)
Event Date 06/22/2017
Event Type  Injury  
Manufacturer Narrative
The initial reporter's complete address is (b)(6). Additional details regarding the patient's clinical course were ascertained from a review of medical records and are as follows: please see the attached file for information ascertained from the medical records. It should be noted that the gore® synecor intraperitoneal biomaterial instructions for use includes warnings and 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 ventral hernia repair on (b)(6) 2007 whereby a gore® dualmesh® plus biomaterial was implanted. The complaint alleges that on(b)(6) 2017, an additional procedure occurred whereby the gore device was explanted. It was reported the patient alleges the following injuries: mesh removal, pain, adhesions, wound vac, additional surgery. Additional event specific information was not provided.
 
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Brand NameGORE® SYNECOR INTRAPERITONEAL 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
katheryn fox
9285263030
MDR Report Key12682599
MDR Text Key277943949
Report Number3003910212-2021-00004
Device Sequence Number1
Product Code FTL
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K152609
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Reporter Occupation Non-Healthcare Professional
Type of Report Initial,Followup
Report Date 11/16/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/22/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date10/24/2019
Device Model NumberGKFV1520
Device Catalogue NumberGKFV1520
Device Lot Number15625679
Was Device Available for Evaluation? No
Was the Report Sent to FDA? No
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured10/24/2016
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: 10/22/2021 Patient Sequence Number: 1
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