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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: C.R. BARD INC. VENTRALIGHT ST MESH; MESH, SURGICAL, POLYMERIC
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C.R. BARD INC. VENTRALIGHT ST MESH; MESH, SURGICAL, POLYMERIC Back to Search Results
Catalog Number 5955460
Device Problems Break (1069); Detachment Of Device Component (1104)
Patient Problem Foreign Body In Patient (2687)
Event Date 02/20/2017
Event Type  malfunction  
Event Description
Ventralight st mesh with echo positioning system malfunctioned.While in patient, yellow anchor came off of the inflation tubing and became lost in subcutaneous tissue of the patient.Surgeon explored the wound carefully to try and find the retained object.Two separate x-rays were taken of the abdomen.Radiologist verified no foreign object detected, however the manufacturer confirmed that the yellow plastic was not x-ray detectable.The thought was they may have been able to see a shadow.All steps were taken to find device, but all attempts were unsuccessful.
 
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Brand Name
VENTRALIGHT ST MESH
Type of Device
MESH, SURGICAL, POLYMERIC
Manufacturer (Section D)
C.R. BARD INC.
100 crossings boulevard
warwick RI 02886
MDR Report Key6386860
MDR Text Key69362680
Report Number6386860
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 User Facility
Reporter Occupation Other
Type of Report Initial
Report Date 02/21/2017,02/24/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/08/2017
Is this a Product Problem Report? Yes
Device Operator Other
Device Expiration Date08/28/2018
Device Catalogue Number5955460
Device Lot NumberHUAU1364
Was Device Available for Evaluation? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA02/21/2017
Event Location Hospital
Date Report to Manufacturer02/21/2017
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage N
Patient Sequence Number1
Patient Age52 YR
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