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

Catalog Number	5954810
Medical Device Problem Codes	Defective Device (2588); Patient-Device Incompatibility (2682); Patient Device Interaction Problem (4001)
Health Effect - Clinical Codes	Abdominal Pain (1685); Pain (1994); Insufficient Information (4580)
Date of Event	10/16/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
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.This emdr represents the bard/davol ventralight st mesh (device #3).Additional emdrs were submitted to represent the bard/davol ventralex st (device #1) and bard/davol ventrio mesh (device #2).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 the implant of unspecified bard/davol ventralex st, ventrio and ventralight st mesh on (b)(6) 2015 and/or (b)(6) 2016 and/or (b)(6) 2020.As reported, the patient is making a claim for an adverse patient outcome against all devices.It is alleged that the patient sustained unspecified injuries on (b)(6) 2016 and (b)(6) 2020.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.
Event or Problem Description
Attorney alleges that the patient underwent surgery for the implant of unspecified bard/davol ventralex st, ventrio and ventralight st mesh on (b)(6) 2015 and/or (b)(6) 2016 and/or (b)(6) 2020.As reported, the patient is making a claim for an adverse patient outcome against all devices.It is alleged that the patient sustained unspecified injuries on (b)(6) 2016 and (b)(6) 2020.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: (b)(6) 2015 ¿ patient was diagnosed with incisional hernia thereby underwent open repair with the implant of ventrio mesh (device #1).Per operative notes, ¿a ventrio mesh (device #1) was placed into defect and sutured.¿ (b)(6) 2016 ¿ patient was diagnosed with recurrent incisional hernia thereby underwent open repair with the implant of ventralex st (device #2).Per operative notes, ¿adhesions were divided.The ventralex st mesh (device #2) was placed beneath the defect as an intraperitoneal underlay and secured using sutures.¿ (b)(6) 2020 ¿ patient had chronic pain and diagnosed recurrent incisional hernia thereby underwent robotic assisted repair with the removal of meshes (device #1, #2) and implant of ventralight st mesh (device #3).Per operative notes, ¿adhesions on hernia was lysed.The previously placed mesh (device #1) was encountered with adhesions were freed up and another mesh (device #2) in preperitoneal space was well incorporated.The mesh (device #1, #2) was excised and removed in its entirety.A bard ventralight st mesh (device #3) was placed to cover the defect and reinforced using sutures.¿ (b)(6) 2020 ¿ patient had abdominal pain thereby medication were provided.
Additional Manufacturer Narrative
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: 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-jan-2020) is considered to be a best estimate.Updated fields: a2, a4, b2, b3, b4, b5, b7, d4 (product catalog no., corporate lot no, expiry date, udi no.), d6a (date of implant), g3, g6, h2, h4, h6, h10.This supplemental emdr represents the bard/davol - ventralight st (device #3).Additional supplemental emdr's were submitted to represent the bard/davol - ventrio mesh (device #1), ventralex st mesh (device #2).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.

• Brand Name: VENTRALIGHT ST MESH
• 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: 11847929
• Report Number: 1213643-2021-03648
• Device Sequence Number: 11640280
• Product Code: FTL
• UDI-Device Identifier: 00801741031687
• UDI-Public: (01)00801741031687(17)220228(10)HUEN1869
• Combination Product (Y/N): N
• Initial Reporter State: RI
• Initial Reporter Country: US
• PMA/510(K) Number: K101851
• 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,Followup
• Report Date (Section B): 08/04/2025

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: 02/28/2022
• Device Catalogue Number: 5954810
• Device Lot Number: HUEN1869
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/30/2021
• Supplement Date Received by Manufacturer: 07/15/2025
• Initial Report FDA Received Date: 05/19/2021
• Supplement Report FDA Received Date: 08/04/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/15/2020
• 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: 37 YR
• Patient Sex: Male
• Patient Weight: 121 KG