MAUDE Adverse Event Report: DAVOL INC., SUB. C.R. BARD, INC. -1213643 VENTRIO ST; SURGICAL MESH

Catalog Number	5950020
Medical Device Problem Codes	Defective Device (2588); Patient-Device Incompatibility (2682)
Health Effect - Clinical Codes	Pain (1994); Scar Tissue (2060); Hernia (2240); Deformity/ Disfigurement (2360)
Date of Event	12/15/2020
Type of Reportable Event	Serious Injury
Event or Problem Description
Attorney alleges that, "on (b)(6) 2020, the patient was implanted with bard/davol ventrio st in the course of an incisional hernia repair surgery." attorney alleges that "further to the implantation with the product, patient suffered the development of hernia recurrence, gastrointestinal complications and chronic pain." attorney alleges that "on (b)(6) 2020, the plaintiff underwent corrective revision surgery and was implanted with bard/davol ventralight st mesh with echo ps positioning system".It is also alleged that the plaintiff sustained injuries including; hernia recurrence, gastrointestinal complications, chronic pain, psychological and emotional injuries.It is alleged that the plaintiff "has suffered injuries, losses, and damages resulting from numerous defects in the product that create an unreasonably high risk of injury with severe permanent adverse health consequences." attorney alleges the plaintiff suffered permanent injuries including scarring, disfigurement, pain and physical disability." it is alleged that the plaintiff continues to undergo medical care and treatment.It is also alleged that the patient sustained personal injury, emotional distress and the device was defective.
Additional 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 permanent injury, hernia recurrence, pain and revision surgery.A review of the manufacturing records was performed and found that the lot was manufactured to specification.The instructions-for-use (ifu) supplied with the device lists hernia recurrence and inflammation as possible complications.This mdr represents the bard/davol ventrio st (device #1).An additional mdr was submitted to represent the bard/davol ventralight st w/ echo (device #2).Should additional information be provided, a supplemental mdr will be submitted.The information provided by bd represents all of the known information at this time.Despite good faith efforts to obtain additional information, the complainant / reporter was unable or unwilling to provide any further patient, product, or procedural details to bd.Not returned.

• Brand Name: VENTRIO ST
• Common Device Name: SURGICAL MESH
• Manufacturer (Section D): DAVOL INC., SUB. C.R. BARD, INC. -1213643; 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 ; 8005566756
• MDR Report Key: 15822885
• Report Number: 1213643-2022-00752
• Device Sequence Number: 6157295
• Product Code: FTL
• UDI-Device Identifier: 00801741031519
• UDI-Public: (01)00801741031519
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K101920
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: Other,Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 10/31/2022

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
• Operator of Device: Health Professional
• Device Expiration Date: 05/28/2021
• Device Catalogue Number: 5950020
• Device Lot Number: HUDT0075
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/25/2022
• Initial Report FDA Received Date: 11/18/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/25/2019
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention; Disability
• Patient Sex: Male