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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BARD VENTRALIGHT ST MESH WITH PS ECHO PS POSITIONING SYSTEM

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BARD VENTRALIGHT ST MESH WITH PS ECHO PS POSITIONING SYSTEM Back to Search Results
Lot Number HUAR2061
Device Problems Break (1069); Detachment Of Device Component (1104)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 07/20/2016
Event Type  malfunction  
Event Description
During the implantation of a bard ventralight st mesh, one of the pieces of the positioning device broke off and fell apart inside of the patient's body. All pieces of the device were found and retrieved. The patient was not harmed. The mesh and all pieces were retrieved and was returned to the company.
 
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Brand NameVENTRALIGHT ST MESH WITH PS ECHO PS POSITIONING SYSTEM
Type of DeviceMESH
Manufacturer (Section D)
BARD
warwick RI 02886
MDR Report Key5878279
MDR Text Key52288318
Report NumberMW5064093
Device Sequence Number1
Product Code FTL
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation
Type of Report Initial
Report Date 08/11/2016
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received08/11/2016
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other
Device Expiration Date05/18/2018
Device Lot NumberHUAR2061
Other Device ID Number00801741031717
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer07/21/2016
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
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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