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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
Catalog Number GKFR2025
Device Problems No Apparent Adverse Event (3189); Insufficient Information (3190)
Patient Problems Not Applicable (3189); No Information (3190); No Clinical Signs, Symptoms or Conditions (4582)
Event Type  Injury  
Manufacturer Narrative

(b)(6). Please note: it is not possible to determine from the information provided if the alleged synecor was an intraperitoneal product or a preperitoneal product. Therefore, gore® synecor intraperitoneal biomaterial was indicated as a default selection. The product details will be updated appropriately if additional information is received. (b)(4). It should be noted that the gore® synecor intraperitoneal biomaterial instructions for use includes warnings and states the following: ¿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, pain, exposure (extrusion), bowel obstruction and recurrence. " "as with any surgical procedure, there are always risks of complications for surgical repair of hernias, with or without mesh, these may include but are not limited to, infection, inflammation, adhesion, fistula formation, seroma formation, perforation, wound dehiscence, wound complications, pain, bowel obstruction, ileus, revision/resurgery, device contraction, fever, hernia recurrence. ¿.

 
Event Description

It was reported to gore that a patient alleges to have underwent repair of an abdominal ventral incisional hernia on an unknown date using a gore® synecor biomaterial (type of biomaterial not specified). It was alleged that ¿¿gore¿s synecor mesh fails to perform as intended, require subsequent surgeries for removal and/or rescission [sic], and have caused severe and irreversible injuries, conditions, and damage to the plaintiff. These defects include, but are not limited to: a. Infection; b. Hernia recurrence; c. Bowel obstruction; d. Severe abdominal pain; e. Adhesion; and f. Hospitalization. ¿ the complaint states: ¿because of its numerous defects, the synecor mesh creates an unreasonable risk of injury and other adverse health consequences for patients, including, but not necessarily limited to, infection, abscesses, fistula, inflammation, chronic pain, scar tissue, organ perforation, nerve damage and pain that plaintiff endured, and forced the need for intensive medical treatment, including but not limited to additional surgeries to repair/remove the defective mesh and the use of pain control and other medications. ¿ it was alleged that ¿the synecor mesh sheet used by plaintiff¿s physician was not substantially changed, modified or altered in any way whatsoever prior to use. The subject synecor mesh sheet reached the plaintiff in such a condition that was unreasonably dangerous to him. The synecor mesh sheet was used in the manner for which it was intended, that is, for abdominal hernia repair. This use resulted in injury to the plaintiff. ¿ the complaint states that the ¿¿plaintiff has sustained and will continue to sustain severe and debilitating pain, serious bodily injury and scarring, mental and physical pain and suffering and has incurred economic loss. ¿ the complaint further alleges that ¿¿the synecor mesh caused plaintiff to suffer severe and debilitating pain, infections, bleeding, and other severe adverse health consequences. ¿ additional, event specific information was not provided. Medical records detailing the above event information have been requested.

 
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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
claire west
1500 n. 4th street
9285263030
MDR Report Key7818985
MDR Text Key118307272
Report Number3003910212-2018-00075
Device Sequence Number1
Product Code FTL
Combination Product (Y/N)N
Reporter Country CodeUS
PMA/PMN NumberK152609
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Reporter Occupation
Type of Report Initial,Followup,Followup,Followup,Followup
Report Date 03/17/2021
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received08/27/2018
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator HEALTH PROFESSIONAL
Device EXPIRATION Date04/21/2019
Device Catalogue NumberGKFR2025
Device LOT Number15010513
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 Manufactured04/21/2016
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: 08/27/2018 Patient Sequence Number: 1
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