• 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 ST 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 ST SURGICAL MESH Back to Search Results
Catalog Number UNKAA086
Device Problems Defective Device (2588); Insufficient Information (3190)
Patient Problems Pain (1994); Disability (2371); Ambulation Difficulties (2544)
Event Type  Injury  
Manufacturer Narrative

Based on the information provided there is no connection that can be at this time between the allegations made by the patient's attorney and any problem with the bard/davol device used to treat the patient's hernia. The patient's attorney did not allege a specific device failure and no medical records have been provided. Based on the information as provided, the implant location of the bard ventralex st mesh is unclear. With the limited information reported at this time, no conclusions can be made. No lot number has been provided; therefore a review of the manufacturing records could not be conducted. Should additional information be provided, a supplemental emdr will be submitted. This file represents the bard ventralex st mesh , an additional emdr has been submitted to document the alleged implant of the bard perfix plug. 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. Not returned.

 
Event Description

The following was alleged by the patient's attorney: on (b)(6) 2014 - the patient underwent the repair of the left inguinal hernia with mesh, plug and patch technique. The attorney alleges during the implant procedure the patient was implanted with a bard/davol perfix plug and a bard/davol ventralex st mesh. The attorney for the patient alleges the patient has experienced severe and permanent bodily injuries, including but not limited to excruciating abdominal pain and swelling, difficulty walking and physical pain and alleges the patient will have to undergo additional surgery to "remove and/or repair the damage and injuries caused by the products. " the attorney further alleges the products are defective and the patient to have suffered future loss of enjoyment of life, permanent injury, permanent scarring and disfigurement.

 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameVENTRALEX ST
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 Key7104945
MDR Text Key94481771
Report Number1213643-2017-01005
Device Sequence Number1
Product Code FTL
Combination Product (Y/N)N
Reporter Country CodeUS
PMA/PMN NumberK101928
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 12/11/2017
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received12/11/2017
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator HEALTH PROFESSIONAL
Device Catalogue NumberUNKAA086
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 Received11/17/2017
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: 12/11/2017 Patient Sequence Number: 1
-
-