• 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. VENTRALISHT ST W/ ECHO 2 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. VENTRALISHT ST W/ ECHO 2 SURGICAL MESH Back to Search Results
Catalog Number 5991015
Device Problems Use of Device Problem (1670); Improper or Incorrect Procedure or Method (2017)
Patient Problems Injury (2348); Foreign Body In Patient (2687)
Event Date 03/28/2019
Event Type  Injury  
Manufacturer Narrative

Based on the events as reported the echo 2 ps was not removed from the patient as prescribed in the instructions-for-use. The root cause is confirmed as use related with no malfunction of the device. The warning section of the instructions-for-use states: ventralight¿ st mesh is the only permanent implant component of the device. The echo 2¿ positioning system (which includes deployment frame, center hoisting suture and all connectors) must be removed from the patient and appropriately discarded. It is not part of the permanent implant. Sample not returned.

 
Event Description

It was reported that on (b)(6) 2019 the patient underwent a robotic assisted laparoscopic ventral incisional hernia repair with a ventralight st w/ echo 2 ps. The surgeon later realized he had not removed the echo 2 ps portion of the device from the implant. On (b)(6) 2019 the patient underwent a laparoscopic procedure for removal of the echo 2 ps. As reported the procedure was uncomplicated.

 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameVENTRALISHT ST W/ ECHO 2
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 sundberg
100 crossings blvd.
warwick, RI 02886
4018258462
MDR Report Key8568633
MDR Text Key143676864
Report Number1213643-2019-03534
Device Sequence Number1
Product Code FTL
Combination Product (Y/N)N
Reporter Country CodeUS
PMA/PMN NumberK170294
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type HEALTH PROFESSIONAL
Reporter Occupation
Type of Report Initial
Report Date 05/01/2019
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received05/01/2019
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator HEALTH PROFESSIONAL
Device Catalogue Number5991015
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received04/09/2019
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
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: 05/01/2019 Patient Sequence Number: 1
-
-