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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
Device Problem Improper or Incorrect Procedure or Method (2017)
Patient Problem Obstruction/Occlusion (2422)
Event Date 01/01/2019
Event Type  Injury  
Manufacturer Narrative

Date of event has been requested. According to the instructions for use (ifu) for gore® synecor intraperitoneal biomaterial, correct surface orientation is important for gore® synecor intraperitoneal biomaterial. Incorrect parietal (non shiny) surface placement with unnecessary contact with internal organs may result in adhesions, erosion, extrusion, fistula, infection, irritation or inflammation, pain, and additional intervention including surgery.

 
Event Description

It was reported by the gore field sales associate that a surgeon used gore® synecor intraperitoneal biomaterial for a hernia repair. The surgeon previously told the fsa, several months ago, that his patient experienced a bowel obstruction following the hernia repair. The surgeon did not report that the bowel obstruction was device related. According to the fsa, the surgeon returned the patient to the operating room to address the obstruction. Later, the surgeon told the fsa that the device had been implanted upside down (with the film side in contact with the peritoneum instead of the viscera). At that time, the surgeon said that they did not consider this event to be caused by the device and instead was likely due to his technique in implanting the device upside down.

 
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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
angela brown
1500 n. 4th street
9285263030
MDR Report Key9733302
MDR Text Key180183274
Report Number3003910212-2020-00023
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
Source Type COMPANY REPRESENTATIVE
Reporter Occupation
Type of Report Initial,Followup,Followup,Followup
Report Date 07/01/2020
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received02/20/2020
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator HEALTH PROFESSIONAL
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
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: 02/20/2020 Patient Sequence Number: 1
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