• 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 5955800
Device Problems Shelf Life Exceeded (1567); Use of Device Problem (1670)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 03/21/2018
Event Type  malfunction  
Manufacturer Narrative
As reported the expired device was inadvertently implanted. Our review shows that the lot was provided to the customer prior to the expiration date. The product is packaged with the expiration clearly displayed on each level of packaging. The instructions-for-use instructs the user to inspect the package prior to use. This event is confirmed to be solely a use related error. Note: 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. Implanted.
 
Event Description
It was reported that on (b)(6) 2018 during a laparoscopic repair of an incarcerated ventral hernia a davol ventralight st w/ echo was implanted that had been retrieved from the hospital inventory. As reported, after the procedure was completed, during a routine documentation of the devices used in the procedure it was noted the expiration date of the mesh was (b)(6) 2018. As reported the surgeon decided to leave the mesh implanted with no further medical or surgical intervention.
 
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 sundberg
100 crossings blvd.
warwick, RI 02886
4018258462
MDR Report Key7412924
MDR Text Key105384380
Report Number1213643-2018-00986
Device Sequence Number1
Product Code FTL
UDI-Device Identifier00801741031779
UDI-Public(01)00801741031779
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K130968
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional
Reporter Occupation
Type of Report Initial
Report Date 04/10/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received04/10/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date01/28/2018
Device Catalogue Number5955800
Device Lot NumberHUAN0488
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 Received03/22/2018
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured02/16/2016
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

-
-