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); Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Abdominal Pain (1685); Adhesion(s) (1695); Hernia (2240); Disability (2371)
Date of Event	06/08/2014
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
At this time no conclusions can be made regarding the bard/davol ventralight st (device #2) used to treat the patient.The patient's attorney alleges adhesions, hernia recurrence, and pain; however, no details have been provided.Recurrence and adhesions are a known inherent risks of surgery and are listed in the instructions-for-use a possible complication.No lot number has been provided; therefore a review of the manufacturing records is not possible.This emdr represents the bard/davol ventralight st (device #2).An additional emdr was submitted to represent the bard/davol ventrio (device #1).Should additional information be provided a supplemental emdr will be submitted.Not returned.
Event or Problem Description
Attorney alleges that on (b)(6) 2012 or (b)(6) 2013, the patient underwent surgery for implant of an unspecified bard/davol ventrio (device #1) or an unspecified bard/davol ventralight st (device #2).The attorney alleges the patient had adhesions, hernia recurrence, and pain.As reported, the patient is making a claim for an adverse patient outcome against the ventrio (device #1) and ventralight 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.".
Event or Problem Description
Attorney alleges that on (b)(6) 2012 or (b)(6) 2013, the patient underwent surgery for implant of an unspecified bard/davol ventrio (device #1) or an unspecified bard/davol ventralight st (device #2).The attorney alleges the patient had adhesions, hernia recurrence, and pain.As reported, the patient is making a claim for an adverse patient outcome against the ventrio (device #1) and ventralight 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) 2012 ¿ patient was diagnosed with ventral hernia thereby underwent repair with the implant of ventrio mesh (device #1).(note: there is no op notes provided for this procedure in medical record) (b)(6) 2013 ¿ patient was diagnosed with incarcerated multiple ventral hernia thereby underwent laparoscopic repair with the implant of ventralight st mesh (device #2).Per op notes, ¿patient had large multiple ventral hernias and previous mesh (device #1 was noted.Adhesions were taken down.A piece of ventralight st mesh (device #2) was placed into abdomen and sutured.¿ (b)(6) 2014 ¿ patient had abdominal pain and diagnosed with two recurrent incarcerated ventrals thereby underwent removal of meshes (device #1, #2).Per op notes, ¿patient had large amount of adhesions including incarcerated bowel that was adherent to the underneath surface of previous meshes.A new ventral hernia was just superior to previous mesh.The 2 pieces of meshes (device #1, #2) were removed in its entirety.A ventralight st using echo ps (device #3) was placed into abdominal cavity and tacked using sorbafix tacker.A piece of xenmatrix mesh (device #4) was placed as an onlay and sutured.¿.
Additional Manufacturer Narrative
At this time no conclusions can be made regarding the bard/davol ventralight st (device #2) used to treat the patient.The patient's attorney alleges adhesions, hernia recurrence, and pain; however, no details have been provided.Recurrence and adhesions are a known inherent risks of surgery and are listed in the instructions-for-use a possible complication.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.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-mar-2012) is considered to be a best estimate.This supplemental emdr represents the bard/davol ventralight st mesh (device #2).An another supplemental emdr was submitted to represent the bard/davol ventrio 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.

• 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: 8659903
• Report Number: 1213643-2019-04527
• Device Sequence Number: 1831733
• Product Code: FTL
• UDI-Device Identifier: 00801741031649
• UDI-Public: (01)00801741031649(17)140328(10)HUWC0269
• 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: 2013
• 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): 07/07/2025

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: 03/28/2014
• Device Catalogue Number: 5954610
• Device Lot Number: HUWC0269
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/09/2019
• Supplement Date Received by Manufacturer: 06/17/2025
• Initial Report FDA Received Date: 05/31/2019
• Supplement Report FDA Received Date: 07/07/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/15/2012
• 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: 30 YR
• Patient Sex: Male