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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DAVOL INC., SUB. C.R. BARD, INC. VENTRIO ST SURGICAL MESH

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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 Death (1802); Hernia (2240); Disability (2371)
Event Type  Death  
Manufacturer Narrative
At this time no conclusions can be made. The plaintiff's attorney alleges wrongful death of the plaintiff, infection, inflammatory reaction, abscess, hernia recurrence etc. , that sent plaintiff to the hospital; "past, present, and future damages, including but not limited to, mental, physical pain and suffering for severe and permanent personal injuries sustained by the plaintiff(s)"; however, no details have been provided. Review of the adverse reaction section of the ifu states that inflammation, infection, allergic reaction, and recurrence of the hernia are possible complications. In regards to the alleged infection, the warning section of the ifu states "if an infection develops, treat the infection aggressively. Consideration should be given regarding the need to remove the prosthesis. An unresolved infection may require removal of the prosthesis. ¿ 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. Not returned.
 
Event Description
Attorney alleges that the patient underwent surgery for implant of an unspecified bard/davol ventrio st on (b)(6) 2016. As reported, the plaintiff is making a claim for an adverse patient outcome against the ventrio st. Attorney alleges, ¿plaintiff¿s death was caused by the wrongful act, neglect, and/or default of bard and davol. Specifically, the defective design and/or manufacturing of the bard ventrio st patch led to the infection and inflammatory reaction, abscess, hernia recurrence, etc. That sent plaintiff to the hospital, while the fraudulent concealment and failure to warn induced plaintiff to obtain the defective mesh product¿. Attorney also alleges that the patient experienced emotional distress 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 plaintiff(s). ".
 
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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
andrew topoulos
100 crossings blvd.
warwick, RI 02886
4018258495
MDR Report Key10030394
MDR Text Key190049970
Report Number1213643-2020-04464
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 05/06/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/06/2020
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 Received05/01/2020
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: 05/06/2020 Patient Sequence Number: 1
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