• 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 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. VENTRIO ST SURGICAL MESH Back to Search Results
Catalog Number UNKAA089
Device Problems Defective Device (2588); Insufficient Information (3190)
Patient Problems Unspecified Infection (1930); Internal Organ Perforation (1987); Hernia (2240)
Event Type  Injury  
Manufacturer Narrative
At this time no conclusions can be made to what extent the bard/davol may have caused or contributed to the reported event. The attorney alleges organ perforation; however no details have been provided. Recurrence and adhesions is a known inherent risk of surgery and is listed in the instructions-for-use a possible complication. Regarding infection the warning section of the instructions-for-use states, ¿if an infection develops, treat the infection aggressively. The prosthesis may not have to be removed. An unresolved infection, however, may require removal of the prosthesis. ¿ the cause of the patient postoperative complications cannot be determined at this time. No lot number has been provided therefore a review of the manufacturing records is not possible at this time. Information is limited. Should additional information be provided a supplemental emdr will be submitted. Not returned.
 
Event Description
Attorney alleges that the patient underwent surgery for implant of an unspecified bard/davol ventrio st on (b)(6) 2013. It is also alleged that the patient began to suffer from infections, adhesions, hernia recurrence, and organ perforation. As reported, the patient is making a claim for an adverse patient outcome against the ventrio st. As reported, the attorney 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. ".
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameVENTRIO 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
jan ling
100 crossings blvd.
warwick, RI 02886
8015652663
MDR Report Key8847842
MDR Text Key152856592
Report Number1213643-2019-06491
Device Sequence Number1
Product Code FTL
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K101920
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type consumer,other
Reporter Occupation Non-Healthcare Professional
Type of Report Initial
Report Date 07/31/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/31/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Catalogue NumberUNKAA089
Was Device Available for Evaluation? No
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received07/19/2019
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: 07/31/2019 Patient Sequence Number: 1
-
-