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U.S. Department of Health and Human Services

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

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W. L. GORE & ASSOCIATES, INC. GORE® SYNECOR® INTRAPERITONEAL BIOMATERIAL MESH, SURGICAL, POLYMERIC Back to Search Results
Model Number GKFR2030
Device Problem Insufficient Information (3190)
Patient Problem Unspecified Infection (1930)
Event Date 07/31/2017
Event Type  Injury  
Manufacturer Narrative
It should be noted that the gore® synecor® intraperitoneal 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® intraperitoneal 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 laparoscopic incisional hernia repair on (b)(6), 2005 whereby a gore® dualmesh® plus biomaterial was implanted and on (b)(6), 2017 whereby a gore® synecor® intraperitoneal biomaterial was implanted. The complaint alleges that on (b)(6), 2016 an additional procedure occurred whereby a gore device was revised. The complaint alleges that on (b)(6), 2017 and (b)(6), 2018, additional procedures occurred whereby the gore devices were explanted. It was reported the patient alleges the following injuries: additional surgeries, pain, adhesions, revision, bowel resection, fistula, infection, wound vac, removal. 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, 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
vanessa rodriguez
1505 n. fourth street
flagstaff, AZ 86004
9285263030
MDR Report Key13653564
MDR Text Key288675988
Report Number3003910212-2022-01341
Device Sequence Number1
Product Code FTL
UDI-Device Identifier00733132635368
UDI-Public00733132635368
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K152609
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 04/22/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/02/2022
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date09/26/2019
Device Model NumberGKFR2030
Device Catalogue NumberGKFR2030
Was Device Available for Evaluation? No
Date Manufacturer Received04/21/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured09/26/2016
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: 03/02/2022 Patient Sequence Number: 1
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