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U.S. Department of Health and Human Services

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

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W.L. GORE & ASSOCIATES ENDOSCOPIC GORE SEAMGUARD BIOABSORBABLE STAPLE LINE REINFORCEMENT MESH, SURGICAL Back to Search Results
Device Problem Insufficient Information (3190)
Patient Problem Blood Loss (2597)
Event Date 06/01/2006
Event Type  Injury  
Manufacturer Narrative
According to the gore® seamguard® bioabsorbable staple line reinforcement instructions for use (ifu), adverse events that may occur and/or require intervention include, but are not limited to: infection, inflammation, adhesions and hematoma.
 
Event Description
The following publication was reviewed: gastroscopically controlled laparoscopic sleeve gastrectomy. The publication reports since june 2006, 38 patients have undergone sleeve gastrectomy. Post surgical bleeding occurred in 1 case and had to be treated surgically.
 
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Brand NameENDOSCOPIC GORE SEAMGUARD BIOABSORBABLE STAPLE LINE REINFORCEMENT
Type of DeviceMESH, SURGICAL
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 Key10243284
MDR Text Key197924267
Report Number3003910212-2020-00115
Device Sequence Number1
Product Code FTM
Combination Product (y/n)N
Reporter Country CodeGM
PMA/PMN Number
K043056
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Reporter Occupation
Type of Report Initial,Followup
Report Date 07/28/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/08/2020
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
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: 07/08/2020 Patient Sequence Number: 1
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