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	Pain (1994); Hernia (2240); Injury (2348); Disability (2371)
Date of Event	01/27/2015
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
At this time no conclusions can be made.The patient's attorney alleges "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"; however, no details have been provided.No lot number has been provided; therefore, a review of the manufacturing records is not possible.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 ventralex st and bard/davol ventrio on (b)(6) 2014 and/or (b)(6) 2015.As reported, the patient is making a claim for an adverse patient outcome against the ventrio.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." it is also alleged that the patient experienced emotional distress and the device was defective.
Additional Manufacturer Narrative
At this time no conclusions can be made.The patient's attorney alleges "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"; however, no details have been provided.No lot number has been provided; therefore, a review of the manufacturing records is not possible.Addendum: h11: this supplemental emdr is submitted to document additional information provided and to correct the brand name and 510(k).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-may-2014) is considered to be a best estimate.Updated fields: a2, b2, b3, b4, b5, b7, d4 (product catalog no., corporate lot no., udi no., expiry date), d6.A (date of implant), d6.B (date of explant), g1, g3, g6, h2, h4, h6, h10, h11.Corrected field: d1 (brand name), g4 (pma/510(k) #), this supplemental emdr represents the bard/davol ventrio st (device #1).An additional emdr was submitted to represent the bard/davol ventralex st (device #3).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.H3 other text: not returned.
Event or Problem Description
Attorney alleges that the patient underwent surgery for implant of an unspecified bard/davol ventralex st and bard/davol ventrio on (b)(6) 2014 and/or (b)(6) 2015 and/or (b)(6) 2015.As reported, the patient is making a claim for an adverse patient outcome against the ventrio.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." it is also alleged that the patient experienced emotional distress and the device was defective.Addendum per additional information provided: on (b)(6) 2014, patient was diagnosed with incarcerated incisional ventral hernia thereby underwent open repair with implant of ventrio st mesh (device #1).Per op notes, "a ventrio st mesh (device #1) was placed, sutured and tacked." on (b)(6) 2015, patient was diagnosed with recurrent ventral incisional hernia thereby underwent open repair with partial explant of ventrio st mesh (device #1) and implant of ventrio st mesh (device #2).Per op notes, "the mesh (device #1) was dissected except the superior part and removed.A ventrio st mesh (device #2) was placed and sutured." on (b)(6) 2015, patient was diagnosed with epigastric incisional hernia thereby underwent open repair with implant of ventralex st mesh (device #3).Per op notes, "a ventralex st mesh (device #3) was placed and sutured." on (b)(6) 2016, patient was diagnosed with incarcerated incisional epigastric hernia thereby underwent laparoscopic repair with implant of synthetic mesh.Per op notes, "omental adhesions identified to the previous mesh (device #3) were reduced and a synthetic mesh was placed and tacked.".

• 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: 9933998
• Report Number: 1213643-2020-03254
• Device Sequence Number: 16304648
• Product Code: FTL
• UDI-Device Identifier: 00801741031557
• UDI-Public: (01)00801741031557(17)160528(10)HUYE1406
• 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: 2014
• 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): 06/24/2025

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: 05/28/2016
• Device Catalogue Number: 5950060
• Device Lot Number: HUYE1406
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/01/2020
• Supplement Date Received by Manufacturer: 06/10/2025
• Initial Report FDA Received Date: 04/08/2020
• Supplement Report FDA Received Date: 06/24/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/15/2014
• 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: Disability; Required Intervention
• Patient Age: 46 YR
• Patient Sex: Female