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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: W. L. GORE & ASSOCIATES, INC. GORE® SEAMGUARD® BIOABSORBABLE STAPLE LINE REINFORCEMENT MESH, SURGICAL

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W. L. GORE & ASSOCIATES, INC. GORE® SEAMGUARD® BIOABSORBABLE STAPLE LINE REINFORCEMENT MESH, SURGICAL Back to Search Results
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Hemorrhage/Bleeding (1888)
Event Date 10/20/2008
Event Type  Injury  
Manufacturer Narrative
No patient identifier have been provided. Therefore, the patient initials reflect the w. L. Gore internal case number. Review of the manufacturing records could not be performed as a valid lot number was not provided. Engineering evaluation could not be performed as the device was not returned. Literature citation: surg obes relat dis. Mar-apr 2015;11(2):296-301. Per the instructions for use (ifu) for the gore® seamguard® bioabsorbable staple line reinforcement, possible adverse reactions may include, but are not limited to: adhesions, hematoma, infection, and inflammation.
 
Event Description
The following literature publication was reviewed: carlos rodríguez-otero luppi, carmen balagué, eduard m. Targarona, sorin mocanu, jesús bollo, carmen martínez, and manel trias. Title: laparoscopic sleeve gastrectomy in patients over 60 years: impact of age on weight loss and co-morbidity improvement. Published online jun 2, 2014 in surgery for obesity and related diseases (surg obes relat dis. Mar-apr 2015;11(2):296-301). 130 patients underwent laparoscopic sleeve gastrectomy (lsg). On all patients, staples reinforced with gore® seamguard® bioabsorbable staple line reinforcement were used. 1 patient required surgical reintervention due to hemoperitoneum. The patient was hemodynamically unstable and required a laparotomy.
 
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Brand NameGORE® SEAMGUARD® BIOABSORBABLE STAPLE LINE REINFORCEMENT
Type of DeviceMESH, SURGICAL
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
ida simson
1505 n. fourth street
flagstaff, AZ 86004
9285263030
MDR Report Key12785736
MDR Text Key280577803
Report Number3003910212-2021-01312
Device Sequence Number1
Product Code FTM
Combination Product (y/n)N
Reporter Country CodeSP
PMA/PMN Number
K030782
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Literature
Reporter Occupation
Type of Report Initial,Followup
Report Date 11/24/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/10/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received10/28/2021
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: 11/10/2021 Patient Sequence Number: 1
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