• 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 Cardiac Arrest (1762); Death (1802); Obstruction/Occlusion (2422)
Event Date 03/06/2019
Event Type  Death  
Manufacturer Narrative
At this time no conclusions can be made to what extent the bard/davol ventrio device may have caused or contributed to the reported event. The patient's attorney alleges death, pneumatosis intestinalis, cardiac arrest, small bowel obstruction, small intestinal necrosis, distributive shock and "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"; no medical records, autopsy, or death certificate 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.
 
Event Description
Attorney alleges that the patient underwent surgery for implant of an unspecified bard/davol ventrio on (b)(6) 2012. As reported, the patient is making a claim for an adverse patient outcome against the ventrio. Attorney alleges wrongful death of the patient on (b)(6) 2019 with pneumatosis intestinalis as a contributing factor. As reported, the autopsy report for the patient indicated that the computed tomography of the abdomen revealed a small bowel obstruction, with transition point at the site of prior hernia repair. It is also alleged that the cause of death was due to small intestinal necrosis, distributive shock and cardiac arrest. 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. " as reported, the patient 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 Key9496543
MDR Text Key172034944
Report Number1213643-2019-12356
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 12/19/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/19/2019
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 Received12/13/2019
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: 12/19/2019 Patient Sequence Number: 1
-
-