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

Catalog Number 5950050

Device Problems Defective Device (2588); Material Deformation (2976); Patient Device Interaction Problem (4001); Migration (4003)

Patient Problems Unspecified Infection (1930); Inflammation (1932); Pain (1994); Fibrosis (3167)

Event Type  Injury  

Event Description

Attorney alleges that on or about (b)(6) 2019, patient was implanted with a bard/davol ventrio st mesh.It is alleged that the device was defective, had the propensity to contract or shrink inside the body, that in turn causes surrounding tissue to be inflamed, become fibrotic, and contract, resulting in injury; had the propensity to "creep", or to gradually elongate and deform when subject to prolonged tension inside the body; the inelasticity of the medical device, causing it to be improperly mated to the delicate and sensitive areas of the vagina and pelvis where they are implanted, and causing pain upon normal daily activities that involve movement in the pelvic region (e.G., intercourse, defecation, walking); the propensity of the medical device for degradation or fragmentation over time, which causes a chronic inflammatory and fibrotic reaction, and results in continuing injury over time; and the creation of non-anatomic condition in the pelvis leading to chronic pain and functional disabilities when the mesh is implanted.Attorney alleges that as a direct and proximate result of the above foregoing defective and unreasonably dangerous conditions, the patient suffered a migration and infection from the implanted mesh causing numerous internal injuries, infection, and patient suffered injury to the body as a whole and sustained constant pain and suffering.

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 disability, mesh migration, deformation, infection, pain and injury.The instructions-for-use (ifu) supplied with the device lists infection as a possible complication.A review of the manufacturing records was performed and found that the lot was manufactured to specification.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 prosthesis.An unresolved infection may require removal of the prosthesis." should additional information be provided, a supplemental emdr will be submitted.Not returned.

• 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: 13200793
• MDR Text Key: 284183248
• Report Number: 1213643-2021-09618
• Device Sequence Number: 1
• Product Code: FTL
• UDI-Device Identifier: 00801741031540
• UDI-Public: (01)00801741031540
• 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: Other,Consumer
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 01/08/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/08/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 05/28/2021
• Device Catalogue Number: 5950050
• Device Lot Number: HUDT0024
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 12/16/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/26/2019
• 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): Other; Disability
• Patient Sex: Female