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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DAVOL INC. VENTRALIGHT ST MESH WITH ECHO PS POSITONING SYSTEM MESH, SURGICAL, POLYMERIC

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DAVOL INC. VENTRALIGHT ST MESH WITH ECHO PS POSITONING SYSTEM MESH, SURGICAL, POLYMERIC Back to Search Results
Model Number 5955600
Device Problem Material Fragmentation (1261)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 01/13/2020
Event Type  malfunction  
Event Description
Ventralight st mesh with echo ps positioning system was used on patient. There was a small yellow piece of silicone that popped off the positioner while in the abdomen. The piece was unable to be retrieved.
 
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Brand NameVENTRALIGHT ST MESH WITH ECHO PS POSITONING SYSTEM
Type of DeviceMESH, SURGICAL, POLYMERIC
Manufacturer (Section D)
DAVOL INC.
160 new boston st
woburn MA 01801
MDR Report Key9732403
MDR Text Key180147882
Report Number9732403
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 Other Health Care Professional
Type of Report Initial
Report Date 01/20/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received02/20/2020
Is this a Product Problem Report? Yes
Device Operator
Device Model Number5955600
Device Catalogue Number5955600
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA01/20/2020
Event Location Hospital
Date Report to Manufacturer02/20/2020
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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