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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BARD SHANNON LIMITED VENTRALIGHT ST MESH MESH, SURGICAL, POLYMERIC

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BARD SHANNON LIMITED VENTRALIGHT ST MESH MESH, SURGICAL, POLYMERIC Back to Search Results
Catalog Number 5955680
Device Problems Break (1069); Device Fell (4014)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 06/30/2020
Event Type  malfunction  
Event Description
Ventralight st mesh with echo ps positioning system blue deployment cord broke while being removed causing yellow anchor to fall into abdomen. Yellow anchor removed at end of procedure. Mesh was implanted. Fda safety report id# (b)(4).
 
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Brand NameVENTRALIGHT ST MESH
Type of DeviceMESH, SURGICAL, POLYMERIC
Manufacturer (Section D)
BARD SHANNON LIMITED
warwick RI 02886
MDR Report Key10232859
MDR Text Key197793510
Report NumberMW5095359
Device Sequence Number1
Product Code FTL
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Risk Manager
Type of Report Initial
Report Date 07/01/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received07/02/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date10/28/2021
Device Catalogue Number5955680
Device Lot NumberHUDX1401
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Was Device Evaluated by Manufacturer?
Is the Device Single Use?
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

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