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); Patient-Device Incompatibility (2682); Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Adhesion(s) (1695); Pain (1994); Hernia (2240); Injury (2348); Disability (2371)
Date of Event	08/24/2015
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
There is no connection that can be made at this time between the reported unspecified post-operative complications and any problem with the bard/davol ventrio st device used to treat the patient.The patient's attorney did not allege a specific device failure or patient adverse event, and no medical records have been provided.Based on the limited information provided at this time, no conclusions can be made.No lot number has been provided; therefore a review of the manufacturing records is not possible at this time.This emdr represents the bard ventrio st.The patient's attorney did not make any allegations regarding the implanted bard flat mesh.Should additional information be provided a supplemental emdr will be submitted.The information provided by bard 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 bard.Not returned.
Event or Problem Description
The following was alleged by the patient's attorney: on (b)(6) 2015 and (b)(6) 2015 the patient underwent surgery for implant of an unspecified bard/davol bard flat mesh or an unspecified bard/davol ventrio st (device #1).As reported, the patient is only making a claim for an adverse patient outcome against the ventrio st (device #1).As reported, the attorney alleges general allegations against the ventrio st 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
There is no connection that can be made at this time between the reported unspecified post-operative complications and any problem with the bard/davol ventrio st device used to treat the patient.The patient's attorney did not allege a specific device failure or patient adverse event, and no medical records have been provided.Based on the limited information provided at this time, no conclusions can be made.No lot number has been provided; therefore a review of the manufacturing records is not possible at this time.This emdr represents the bard ventrio st.The patient's attorney did not make any allegations regarding the implanted bard flat mesh.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-apr-2014) is considered to be a best estimate.Updated fields: a2, b2, b3, b4, b5, b7, d3, d4 (product catalog no, corporate lot no, expiry date), d6a (date of implant), d6b (date of explant), g1, g3, g6, h2, h4, h6, h10.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
The following was alleged by the patient's attorney: on (b)(6) 2015 and (b)(6) 2015 the patient underwent surgery for implant of an unspecified bard/davol bard flat mesh or an unspecified bard/davol ventrio st (device #1).As reported, the patient is only making a claim for an adverse patient outcome against the ventrio st (device #1).As reported, the attorney alleges general allegations against the ventrio st 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) 2015- patient was diagnosed with incisional hernia thereby underwent open repair implant of ventrio st mesh (device 1).Per op notes, ¿hernia sac was identified in the left paramedian area.It is repaired with ventrio st mesh, tacked and sutured¿.(b)(6) 2015- patient was diagnosed with recurrent ventral hernia, thereby underwent open repair with explant of ventrio st mesh (device 1) and implant of bard soft mesh (device 2).Per op notes, ¿adhesiolysis was performed and the hernia defect was identified with presence of entire piece of ventrio st mesh (device 1) within the defect which was excised.A bard soft mesh (device 2) was placed and sutured¿.

• 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: 7428646
• Report Number: 1213643-2018-01073
• Device Sequence Number: 19261875
• Product Code: FTL
• UDI-Device Identifier: 00801741031557
• UDI-Public: (01)00801741031557(17)160428(10)HUYD0812
• 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: 2015
• Device Explanted Year: 2015
• Reporter Type: Manufacturer
• Report Source: Other,Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/30/2025

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: 04/28/2016
• Device Catalogue Number: 5950060
• Device Lot Number: HUYD0812
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/02/2018
• Supplement Date Received by Manufacturer: 10/09/2025
• Initial Report FDA Received Date: 04/13/2018
• Supplement Report FDA Received Date: 10/30/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/15/2014
• 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 Age: 76 YR
• Patient Sex: Male