• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DAVOL INC., SUB. C.R. BARD, INC. -1213643 VENTRALIGHT ST W/ ECHO SURGICAL MESH

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

DAVOL INC., SUB. C.R. BARD, INC. -1213643 VENTRALIGHT ST W/ ECHO SURGICAL MESH Back to Search Results
Catalog Number 5955600
Device Problem Material Separation (1562)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 04/16/2021
Event Type  malfunction  
Manufacturer Narrative
As reported, the bard/davol ventralight st w/echo ps mesh was stuck in the trocar and the hydrogel barrier separated. It is reported that the subject device is being returned for evaluation; however at this time it has not been received. Based on the information available, no conclusions can be made. A review of manufacturing records indicate product was manufactured to specification. To date, this is the only complaint reported for this manufacturing lot of 112 units released for distribution in (b)(4) 2020. If/when the sample is returned and evaluated, a supplemental mdr will be submitted. The information provided by bd represents all of the known information at this time. Despite good faith efforts to obtain additional information, the complainant / reporter was unable or unwilling to provide any further patient, product, or procedural details to bd.
 
Event Description
As reported, during a laparoscopic ipom procedure on (b)(6) 2021, the bard/davol ventralight st mesh w/ echo ps was hydrated for 1-3 seconds, rolled and inserted through a 10mm trocar. The mesh got stuck in the trocar and could not be rolled out. The surgeon tried pulling the mesh through with the grasping forceps, this did not help. The mesh was withdrawn from the trocar, rolled out and rolled back up to be reinserted. It was noticed that the st barrier was no longer present at one point. As reported, the mesh may not have been rolled tight enough, therefore got stuck in the trocar and was damaged during removal from the trocar with the grasping forceps. The ventralight st mesh was discarded and a bard/davol ventralight st mesh w/ echo 2 ps was used to complete the case. There was no reported patient injury. The surgeon is a new user of this product.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameVENTRALIGHT ST W/ ECHO
Type of DeviceSURGICAL MESH
Manufacturer (Section D)
DAVOL INC., SUB. C.R. BARD, INC. -1213643
100 crossings blvd.
warwick RI 02886
Manufacturer (Section G)
BARD SHANNON LIMITED -3005636544
san geronimo industrial park
lot #1, road #3, km 79.7
humacao PR 00791
Manufacturer Contact
andrew topoulos
100 crossings blvd.
warwick, RI 02886
8005566756
MDR Report Key11852105
MDR Text Key251680712
Report Number1213643-2021-20123
Device Sequence Number1
Product Code FTL
Combination Product (y/n)N
Reporter Country CodeGM
PMA/PMN Number
K130968
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation Non-Healthcare Professional
Type of Report Initial,Followup
Report Date 05/19/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/19/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date12/28/2021
Device Catalogue Number5955600
Device Lot NumberHUDZ0835
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer05/25/2021
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received05/19/2021
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured02/05/2020
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 05/19/2021 Patient Sequence Number: 1
-
-