• 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. VENTRIO MESH 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. VENTRIO MESH SURGICAL MESH Back to Search Results
Catalog Number UNKAA079
Device Problems Defective Device (2588); Insufficient Information (3190)
Patient Problems Death (1802); Injury (2348); Disability (2371)
Event Date 01/10/2018
Event Type  Death  
Manufacturer Narrative
At this time no conclusions can be made. The patient's attorney alleges wrongful death and general allegations for past, present, and future damages, including but not limited to, mental and physical pain and suffering for severe and permanent personal injuries sustained by the patient; however, no details have been provided. No lot number has been provided; therefore, a review of the manufacturing records is not possible. Should additional information be provided a supplemental emdr will be submitted. This emdr represents the ventrio mesh (device #1); an additional emdr was submitted to represent the ventrio st mesh (device #2). Not returned.
 
Event Description
Attorney alleges that the patient underwent surgery for implant of unspecified bard/davol ventrio mesh on (b)(6) 2012 and ventrio st mesh on (b)(6) 2018. As reported, the patient is making a claim for an adverse patient outcome against both meshes. Attorney alleges wrongful death of the patient on (b)(6) 2018. Attorney also alleges general allegations for "past, present, and future damages, including but not limited to, mental and physical pain and suffering for severe and permanent personal injuries sustained by the patient. " it is also alleged that the plaintiff experienced emotional distress and the device was defective.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameVENTRIO MESH
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
andrew topoulos
100 crossings blvd.
warwick, RI 02886
4018258495
MDR Report Key9600385
MDR Text Key175350395
Report Number1213643-2020-00367
Device Sequence Number1
Product Code FTL
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K100229
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type consumer,other
Reporter Occupation
Type of Report Initial
Report Date 01/17/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/17/2020
Is this an Adverse Event Report? Yes
Device Operator
Device Catalogue NumberUNKAA079
Was Device Available for Evaluation? No
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received01/13/2020
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: 01/17/2020 Patient Sequence Number: 1
-
-