• 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. MESH -VENTRALEX 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. MESH -VENTRALEX SURGICAL MESH Back to Search Results
Catalog Number 0010301
Device Problems Material Separation (1562); Torn Material (3024)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 01/05/2017
Event Type  malfunction  
Manufacturer Narrative
The sample has been received, however at this time the evaluation is in progress and root cause has not been determined. A supplemental mdr will be sent when the evaluation has been completed. 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 prior to use of a bard ventralex hernia patch the ring was found to have been detached from the patch. Another device was used to complete the procedure, there was no injury to the patient.
 
Manufacturer Narrative
This is an addendum to the initial mdr as the sample evaluation has been completed. Visual examination at unaided eye and under magnification was conducted. Initial observation confirms the ring was intact within the containment sleeve and the containment sleeve being partially separated from the patch. It was observed that the end sew line was not locked causing the loose monofilament. In addition, the condition of missing stitches due to loose monofilament at the end of sewing pattern was observed. This is the cause of the containment sleeve to partially separate from the patch. Therefore, the condition of the returned sample is confirmed as being related to the manufacturing process. As a result of this complaint the proper execution of visual inspections for sewing defects was discussed and reinforced to the manufacturing line operators. A review of the manufacturing records found that the lot was manufactured to specification with no anomalies noted.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameMESH -VENTRALEX
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 Key6322369
MDR Text Key67231694
Report Number1213643-2017-00092
Device Sequence Number1
Product Code FTL
Combination Product (y/n)N
Reporter Country CodeFR
PMA/PMN Number
K132441
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,user facility
Reporter Occupation Pharmacist
Type of Report Initial,Followup
Report Date 03/03/2017
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received02/10/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date10/28/2019
Device Catalogue Number0010301
Device Lot NumberHUAR2008
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer01/31/2017
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received02/09/2017
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured05/27/2016
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

-
-