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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DAVOL MANUFACTURING SUBSIDIARY OF C.R. BARD, INC. VENTROLIGHT, ST MESH WITH ECHO PS MESH, SURGICAL, POLYMERIC

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DAVOL MANUFACTURING SUBSIDIARY OF C.R. BARD, INC. VENTROLIGHT, ST MESH WITH ECHO PS MESH, SURGICAL, POLYMERIC Back to Search Results
Model Number 5955450
Device Problems Break (1069); Difficult to Remove (1528); Detachment of Device or Device Component (2907)
Patient Problem Device Embedded In Tissue or Plaque (3165)
Event Date 10/09/2018
Event Type  malfunction  
Event Description
A (b)(6) male admitted for repair of recurrent umbilical hernia on (b)(6) 2018. While undergoing a robotic repair of the hernia and during placement of the new mesh (over prior mesh), the inflation tubing (and placement balloon) broke in half. A yellow (pliable) piece of plastic located on the inflation tubing fell off during placement of the mesh. The approximate size of the plastic piece is "less than 1 cm and the diameter of cooked grain of rice". Surgeon explored abdomen, wound and surrounding area and plastic piece was not found - the incision was closed. Patient was transferred to recovery room in good condition.
 
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Brand NameVENTROLIGHT, ST MESH WITH ECHO PS
Type of DeviceMESH, SURGICAL, POLYMERIC
Manufacturer (Section D)
DAVOL MANUFACTURING SUBSIDIARY OF C.R. BARD, INC.
warwick RI 02886
MDR Report Key7960495
MDR Text Key123727040
Report NumberMW5080524
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 Other Health Care Professional
Type of Report Initial
Report Date 10/10/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/11/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date06/28/2020
Device Model Number5955450
Device Catalogue Number5955450
Device Lot NumberHUCP2523
Was Device Available for Evaluation? No
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

Patient Treatment Data
Date Received: 10/11/2018 Patient Sequence Number: 1
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