• 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. 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. VENTRALEX SURGICAL MESH Back to Search Results
Model Number 0010303
Device Problems Defective Device (2588); Insufficient Information (3190)
Patient Problems Adhesion(s) (1695); Hernia (2240); Disability (2371)
Event Date 03/09/2015
Event Type  Injury  
Manufacturer Narrative

Currently, it is unknown to what extent the device may have caused or contributed to the reported event. Based on the information provided, it is alleged the patient experienced hernia recurrence and adhesions. Both recurrence and adhesions are known inherent risks of hernia repair surgery and are identified in the adverse reaction section of the instructions-for-use as a possible complication. If additional event and/or evaluation information is obtained, a follow up mdr will be submitted. This file represents the ventralex (device #2) implanted in (b)(6) 2010. A second emdr has been submitted to address the other ventralex mesh (device #1) implanted in (b)(6) 2010. Not returned to manufacturer.

 
Event Description

The following was reported to davol by the patient's attorney: (b)(6) 2010 - the patient underwent surgery for repair of a ventral hernia, a bard ventralex mesh, (b)(4) and lot number hutl0021 (device #1) was implanted to repair the hernia defect. (b)(6) 2010 - the patient underwent an additional surgery to repair the recurrent hernia defect and take down adhesions that had formed. A ventralex mesh, (b)(4) and lot number huub0353 (device #2) was implanted to repair the hernia defect. (b)(6) 2015 - the patient underwent an additional surgery to repair the hernia defect, take down adhesions, and remove portions of the old mesh. During this procedure a sepramesh was implanted. The attorney alleges the patient has suffered and will continue to suffer pain and was injured severely and permanently.

 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameVENTRALEX
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
steven figueroa
100 crossings blvd.
warwick, RI 02886
4018258460
MDR Report Key7150606
MDR Text Key95905755
Report Number1213643-2017-01112
Device Sequence Number1
Product Code FTL
Combination Product (Y/N)N
Reporter Country CodeUS
PMA/PMN NumberK021736
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type CONSUMER,OTHER
Reporter Occupation ATTORNEY
Type of Report Initial
Report Date 12/28/2017
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received12/28/2017
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator HEALTH PROFESSIONAL
Device EXPIRATION Date02/28/2015
Device MODEL Number0010303
Device Catalogue Number0010303
Device LOT NumberHUUB0353
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received12/04/2017
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured02/25/2010
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: 12/28/2017 Patient Sequence Number: 1
-
-