• 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. 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. VENTRALIGHT ST W/ECHO SURGICAL MESH Back to Search Results
Catalog Number 5955600
Device Problems Use of Device Problem (1670); Detachment of Device or Device Component (2907); Torn Material (3024)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 02/07/2017
Event Type  Injury  
Manufacturer Narrative
Remediate mdr event/report type per protocol (b)(4) and capa (b)(4). Corrected dt questions #5 from "serious injury" and #7 to "malfunction. ".
 
Manufacturer Narrative
A review of the manufacturing records was performed and found that the lot was manufactured to specification. It is reported that the sample is being returned for evaluation. However, photos of the echo ps were provided and a review of the photos finds the condition of the echo ps to be consistent with the device having been damaged when being pulled through a trocar. Additionally, the photo review shows all components of the echo ps to be accounted for. Based on the events as reported, the user did not follow the instructions for removal as prescribed in the ifu. Step 10 states "begin removal of the echo ps positioning system by pulling it up to the tip of the trocar. Remove both the echo ps positioning system and trocar simultaneously. The ifu also notes the user should verify that the echo ps positioning system including the balloon, all mesh connectors, and the inflation tube is fully intact after removal. As reported the event was user related and there was no device malfunction. If / when the sample is returned an evaluation will be performed. If the evaluation finds differently a supplemental mdr will be submitted. The information provided by bard 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 bard.
 
Event Description
It was reported that during a case using a bard ventralight st w/ echo ps the user attempted to remove the echo ps through a trocar. When she did this the balloon tore, and components of the device had to be removed from the abdomen. There was no patient injury and the mesh remains intact and implanted in the patient.
 
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.
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
laura berg
100 crossings blvd.
warwick, RI 02886
4018258462
MDR Report Key6366292
MDR Text Key106423892
Report Number1213643-2017-00134
Device Sequence Number1
Product Code FTL
Combination Product (y/n)N
Reporter Country CodeAS
PMA/PMN Number
K130968
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,health professional
Reporter Occupation
Type of Report Initial,Followup
Report Date 06/22/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/28/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date07/31/2018
Device Catalogue Number5955600
Device Lot NumberHUAU1976
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received05/31/2017
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured08/31/2016
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: 02/28/2017 Patient Sequence Number: 1
-
-