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U.S. Department of Health and Human Services

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

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W. L. GORE & ASSOCIATES, INC. GORE® SYNECOR® PREPERITONEAL BIOMATERIAL MESH, SURGICAL, POLYMERIC Back to Search Results
Model Number GKWV1015
Device Problem Insufficient Information (3190)
Patient Problem Unspecified Infection (1930)
Event Date 04/26/2019
Event Type  Injury  
Manufacturer Narrative
It should be noted that the gore® synecor preperitoneal 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® synecor preperitoneal biomaterial instructions for use also states: ¿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 ventral/incisional hernia repair on (b)(6) 2018 whereby a gore® dualmesh® plus biomaterial was implanted. The complaint alleges that on (b)(6) 2019, an additional procedure occurred whereby the gore device was explanted. It was reported the patient alleges the following injuries: foreign body giant cell reaction, mesh detachment, infection, hernia recurrence, surgery to remove mesh, and severe and chronic pain/discomfort. Additional event specific information was not provided.
 
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Brand NameGORE® SYNECOR® PREPERITONEAL 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
megan reigh
1505 n. fourth street
flagstaff, AZ 86004
9285263030
MDR Report Key12509519
MDR Text Key272751188
Report Number3003910212-2021-01290
Device Sequence Number1
Product Code FTL
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K163576
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Other
Reporter Occupation Non-Healthcare Professional
Type of Report Initial,Followup,Followup
Report Date 02/11/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/21/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date09/05/2020
Device Model NumberGKWV1015
Device Catalogue NumberGKWV1015
Was Device Available for Evaluation? No
Date Manufacturer Received01/31/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured09/06/2017
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: 09/21/2021 Patient Sequence Number: 1
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