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

Catalog Number	5950060
Medical Device Problem Codes	Defective Device (2588); Material Deformation (2976); Insufficient Device Problem Information (3190); Migration (4003)
Health Effect - Clinical Codes	Abdominal Pain (1685); Adhesion(s) (1695); Unspecified Infection (1930); Pain (1994); Hernia (2240); Injury (2348); Disability (2371)
Date of Event	11/29/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
At this time no conclusions can be made regarding the bard/davol ventrio st (device #2) used to treat the patient.The patient's attorney did allege injuries and revision surgery; however, no details have been provided.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 bard flat mesh (device #1).Should additional information be provided a supplemental emdr will be submitted.Not returned.
Event or Problem Description
Attorney alleges that the patient underwent surgery for implant of an unspecified bard/davol bard mesh (device #1) on (b)(6) 2016 and an unspecified bard/davol ventrio st (device #2) on (b)(6) 2017.It is also alleged by patient's attorney that the patient had unspecified injuries related to a defect in the bard mesh (device #1) and ventrio st (device #2), and underwent revision surgery on (b)(6) 2017 and (b)(6) 2017.As reported, the patient is making a claim for an adverse patient outcome against the bard mesh (device #1) and the ventrio st (device #2).As reported, the attorney alleges 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 patient.".
Additional Manufacturer Narrative
At this time no conclusions can be made regarding the bard/davol ventrio st (device #2) used to treat the patient.The patient's attorney did allege injuries and revision surgery; however, no details have been provided.No lot number has been provided therefore a review of the manufacturing records is not possible.Addendum: this supplemental emdr is submitted to document additional information provided.Root cause is inconclusive, no conclusion can be made as to the extent to which the implant may have caused or contributed to the patient's postoperative course.Note, the manufacturing date (15-feb-2017) is considered to be a best estimate.This supplemental emdr represents the bard/davol ventrio st (device #2).An additional supplemental emdr was submitted to represent the bard/davol bard flat mesh (device #1).Note: section a through f - 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.
Event or Problem Description
Attorney alleges that the patient underwent surgery for implant of an unspecified bard/davol bard mesh (device #1) on (b)(6) 2016 and an unspecified bard/davol ventrio st (device #2) on (b)(6) 2017.It is also alleged by patient's attorney that the patient had unspecified injuries related to a defect in the bard mesh (device #1) and ventrio st (device #2) and underwent revision surgery on (b)(6) 2017.As reported, the patient is making a claim for an adverse patient outcome against the bard mesh (device #1) and the ventrio st (device #2).As reported, the attorney alleges 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 patient." addendum per additional information provided: (b)(6) 2016 - patient was diagnosed with two ventral hernias thereby underwent open repair with implant of bard flat mesh (device 1).Per op notes, ¿two ventral hernia sacs were noted and reduced.Both hernias were combined.A bard flat mesh (device 1) was placed and sutured.¿ (b)(6) 2017 - patient was diagnosed with recurrent multiple ventral hernias thereby underwent open repair with excision of bard flat mesh (device 1) and implant of ventrio st (device 2).Per op notes, ¿prior scar was excised.Adhesions were lysed.Multiple hernia defects were noted and reduced.The prior mesh (device 1) was noted and excised entirely.A ventrio st (device 2) was placed and tacked using sutures.¿ (b)(6) 2017 - patient was diagnosed with infected mesh and recurrent ventral hernia with abdominal pain thereby underwent open repair with excision of ventrio st (device 2).Per op notes, ¿the old mesh (device 2) and tacks were noted curled and completely detached from the abdominal wall.Some fibro purulent material was drained.Adhesions were removed.The infected old mesh (device 2) was excised entirely.The hernia was repaired with sutures.¿.

• 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 ; 4018258495
• MDR Report Key: 9079078
• Report Number: 1213643-2019-08866
• Device Sequence Number: 14072941
• Product Code: FTL
• UDI-Device Identifier: 00801741031557
• UDI-Public: (01)00801741031557(17)190228(10)HUBP0552
• Combination Product (Y/N): N
• Initial Reporter State: RI
• Initial Reporter Country: US
• PMA/510(K) Number: K101920
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: Other,Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/04/2025

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: 02/28/2019
• Device Catalogue Number: 5950060
• Device Lot Number: HUBP0552
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/27/2019
• Supplement Date Received by Manufacturer: 11/12/2025
• Initial Report FDA Received Date: 09/17/2019
• Supplement Report FDA Received Date: 12/04/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 02/15/2017
• 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: Disability; Required Intervention
• Patient Age: 62 YR
• Patient Sex: Female