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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 Problems Use of Device Problem (1670); Microbial Contamination of Device (2303); Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Fistula (1862); Unspecified Infection (1930); Hernia (2240)
Event Date 04/13/2020
Event Type  Injury  
Manufacturer Narrative
Additional device utilized in procedure: item #gkfc12/lot #21496599/udi # (b)(4)/mfr report #3003910212-2020-00099. According to the instructions for use (ifu) for gore® synecor intraperitoneal biomaterial, 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, adhesions and related harms, bleeding, bowel obstruction, dysphagia, erosion or extrusion and related harms, exposure or protrusion and related harms, fever, fistula, gerd recurrence,hernia recurrence, ileus, increased procedure time and related harms, irritation or inflammation, infection, lung function,impairment, pain, paresthesia, perforation, revision/re-surgery, seroma or hematoma and related harms, wound complications and wound dehiscence.
 
Event Description
It was reported to gore by the field sales associate that approximately 5 weeks ago the surgeon performed a lap incisional hernia repair, while also performing concomitant ileostomy and colostomy take down and periumbilical hernia. The surgeon reported about a week ago (4 weeks post op) the patient presented with a mesh infection and necrotizing fasciitis. The surgeon removed the two pieces of gore® synecor intraperitoneal biomaterial. The surgeon reported there was no adhesion issues, but felt the bioa layer remained on the peritoneum. It was reported the surgeon went back in the patient yesterday and said it appeared that the bioa had now adhered to the bowel and fistulas were present. Reportedly, the surgeon was not certain the fistulas were due to the bioa and he was not certain the infection was due to the gore® synecor intraperitoneal biomaterial. It was reported the surgeon was looking for guidance and trying to piece the information together.
 
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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 Key10063512
MDR Text Key191258785
Report Number3003910212-2020-00098
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
Source Type company representative
Reporter Occupation
Type of Report Initial,Followup,Followup
Report Date 08/21/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/15/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model NumberGKFV1520
Device Catalogue NumberGKFV1520
Device Lot Number21139574
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
Date Device Manufactured09/10/2019
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: 05/15/2020 Patient Sequence Number: 1
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