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 Bacterial Infection (1735); Seroma (2069); Hernia (2240)

Event Date 01/16/2019

Event Type  Injury  

Manufacturer Narrative

No conclusions can be made.The patient's attorney alleges adverse patient outcome associated with the hernia mesh used to treat the patient including hernia recurrence, seroma, bacterial infection and surgical intervention.The instructions-for-use supplied with the device lists hernia, seroma and infection as possible complications.In regards to the infection, the warnings section of the ifu states "if an infection develops, treat the infection aggressively.Consideration should be given regarding the need to remove the mesh.An unresolved infection may require removal of the mesh." no lot number has been provided; therefore, a review of the manufacturing records is not possible.This emdr represents the bard/davol ventrio st (device #2).An additional emdr was submitted to represent the bard/davol ventrio st (device #1).Should additional information be provided, a supplemental emdr will be submitted.Not returned.

Event Description

Attorney alleges that on (b)(6) 2018, the patient underwent surgery for repair of a ventral hernia and a ventrio st was implanted to repair the hernia defect.On (b)(6) 2018, the patient was admitted to have surgery due to abdominal pain in the same area affected in the operation of (b)(6) 2018.As a part of the ventral hernia repair operation, the ventrio st hernia patch was removed and a new ventrio st hernia patch was placed.In both surgical interventions, the surgeon informed the patient that the mesh was placed due a problem with the hernia.On (b)(6) 2019, the patient was admitted in the hospital to have surgery as the patient presented with clinical symptoms of seroma and a bacterial skin infection in the same area that had been operated previously.The patient was discharged on (b)(6) 2019 after being stabilized by a battery of medications.Later, in (b)(6) 2019, the patient was admitted to once again address additional complications presenting as a result of the aforementioned surgeries.In order to ultimately resolve the hernia situation, the patient underwent an operation and was hospitalized until (b)(6) 2019 and was later referred home and assigned a nurse.It is alleged that the patient suffered physical, emotional damage, severe mental anguish, pain and pain and suffering.It is alleged that apart from invasion into the body on multiple occasions several times, as described, the patient has suffered multiple complications and pain that have lasted several years, until today.It is further alleged that the device is defective.

• 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: 11023554
• MDR Text Key: 222003673
• Report Number: 1213643-2020-11240
• 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: 12/16/2020

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: 12/04/2020
• Initial Date FDA Received: 12/16/2020
• 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): Hospitalization; Required Intervention