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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 BSGEC60AAC
Device Problems Material Twisted/Bent (2981); Firing Problem (4011)
Patient Problem Insufficient Information (4580)
Event Date 05/04/2021
Event Type  malfunction  
Event Description
Product did not fire properly. Seamguard strings got tangled. Product disposed of and another seamguard was used, which did fire properly.
 
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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 Key11811781
MDR Text Key250278878
Report Number11811781
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 05/04/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received05/12/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue NumberBSGEC60AAC
Device Lot Number22404710
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 FDA05/04/2021
Event Location Hospital
Date Report to Manufacturer05/12/2021
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?
Type of Device Usage Unkown

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