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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: W. L. GORE & ASSOCIATES, INC. SEAMGUARD MESH, SURGICAL, POLYMERIC

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W. L. GORE & ASSOCIATES, INC. SEAMGUARD MESH, SURGICAL, POLYMERIC Back to Search Results
Catalog Number 12BSGEC60A
Device Problem Break (1069)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 03/16/2020
Event Type  malfunction  
Event Description
Product defect: seamguard. 2 items from the same lot. First seamguard had a rip in the fabric. Second seamguard had the string break after it was already deployed in the patient. Surgeon was able to retrieve all bits of string but it was broken.
 
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Brand NameSEAMGUARD
Type of DeviceMESH, SURGICAL, POLYMERIC
Manufacturer (Section D)
W. L. GORE & ASSOCIATES, INC.
301 airport rd.
elkton MD 21921
MDR Report Key10069930
MDR Text Key191430369
Report Number10069930
Device Sequence Number1
Product Code FTL
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source User Facility
Reporter Occupation Risk Manager
Type of Report Initial
Report Date 03/17/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received05/19/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number12BSGEC60A
Device Lot Number21632003
Was Device Available for Evaluation? No Answer Provided
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? Yes
Date Report Sent to FDA03/17/2020
Event Location Hospital
Date Report to Manufacturer05/19/2020
Was Device Evaluated by Manufacturer? No Answer Provided
Is the Device Single Use? No Answer Provided
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

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