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

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).".

• Brand Name: VENTRIO ST
• Type of Device: SURGICAL 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 Key: 10030394
• MDR Text Key: 190049970
• Report Number: 1213643-2020-04464
• Device Sequence Number: 1
• Product Code: FTL
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K101920
• Number of Events Reported: 1
• 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

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: UNKAA089
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 05/01/2020
• Initial Date FDA Received: 05/06/2020
• 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 Sequence Number: 1
• Patient Outcome(s): Death; Required Intervention; Disability