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

Catalog Number	5954610
Medical Device Problem Codes	Defective Device (2588); Patient-Device Incompatibility (2682); Patient Device Interaction Problem (4001)
Health Effect - Clinical Codes	Pain (1994); Hernia (2240); Insufficient Information (4580)
Date of Event	05/19/2014
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 ventralex mesh (device #2).An additional emdr was submitted to represent the bard/davol sepramesh composite ip (device #1).Should additional information be provided, a supplemental emdr will be submitted.
Event or Problem Description
Attorney alleges that the patient underwent surgery for implant of unspecified bard/davol ventralex on (b)(6) 2011, marlex mesh (bard flat mesh) on (b)(6) 2014 and a sepramesh composite ip.As reported, the patient is making a claim for an adverse patient outcome against sepramesh composite ip and ventralex.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 implant of unspecified bard/davol ventralex on (b)(6) 2011, marlex mesh (bard flat mesh) on (b)(6) 2014 and a sepramesh composite ip.As reported, the patient is making a claim for an adverse patient outcome against sepramesh composite ip and ventralex.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) 2011 ¿ patient was diagnosed with recurrent ventral hernia thereby underwent laparoscopic repair with the implant of ventralight st mesh (device 2).Per operative notes, ¿the adhesion to old mesh and hernia sac was identified.A ventralight st mesh (device 2) was placed into defect and sutured.¿ (note: there is no product identifier provided for previously implanted old mesh which was seen during this procedure was unknown).(b)(6) 2014 ¿ patient was diagnosed with recurrent ventral hernia thereby underwent open repair with the removal of mesh and implant of bard flat mesh (device 3).Per operative notes, ¿a fascial defect was freed out from the hernia sac and underlying mesh (device 2) which was subsequently removed.A piece of bard flat mesh (device 3) was placed along the posterior sheath using sutures.¿ (note: there is no indication in the medical records provided that the patient was implanted with a sepramesh ip (device 1)).
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: h11: this supplemental emdr is submitted to document additional information provided and to correct the date of implant, brand name and pma/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.Updated fields: a2, b2, b3, b4, b5, b7, d4 (product catalog no., udi no.), d6b (date of explant), g3, g6, h2, h6, h10, h11.Corrected fields: d6a (date of implant), d1 (brand name), g4 (pma/510(k)).This supplemental emdr represents the bard/davol¿ ventralight st mesh (device 2).An additional supplemental emdr was submitted to represent the bard/davol - sepramesh ip (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.H3 other text: not returned.

• 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: 12186534
• Report Number: 1213643-2021-06312
• Device Sequence Number: 19526053
• Product Code: FTL
• UDI-Device Identifier: 00801741031649
• UDI-Public: (01)00801741031649
• 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: 2011
• Device Explanted Year: 2014
• Reporter Type: Manufacturer
• Report Source: Other,Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/15/2025

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 Catalogue Number: 5954610
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/13/2021
• Supplement Date Received by Manufacturer: 09/22/2025
• Initial Report FDA Received Date: 07/18/2021
• Supplement Report FDA Received Date: 10/15/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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: 30 YR
• Patient Sex: Male