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

Catalog Number	5954680
Medical Device Problem Code	Patient-Device Incompatibility (2682)
Health Effect - Clinical Codes	Adhesion(s) (1695); Hernia (2240)
Date of Event	04/18/2019
Type of Reportable Event	Serious Injury
Event or Problem Description
Per information provided: on (b)(6) 2015 - patient was diagnosed with ventral and umbilical hernias thereby underwent open repair with implant of ventrio st (device 1).Per op notes, "midline incision was made.Fascia was opened.Underneath the rectus muscle on both hernias a space was created.A ventrio st (device 1) was placed and sutured." on (b)(6) 2016 - patient was diagnosed with recurrent incisional hernia thereby underwent open repair with implant of bard flat mesh (device 2).Per op notes, "previous midline incision was removed.The fascia was freed.A bard flat mesh was placed in the defect and secured using sutures." (note: there is no visualization of ventrio st (device 1) in this procedure).On (b)(6) 2017 - patient was diagnosed with recurrent incisional hernia thereby underwent open repair with excision of ventrio st (device 1), bard flat mesh (device 2) and implant of ventralight st (device 3).Per op notes, "the old mesh (device 1 and 2) was noted and dissected out.The old meshes (device 1 and 2) were excised and removed entirely.The hernia defect was noted and reduced.A ventralight st (device 3) was placed and sutured.The mesh was tacked lateral borders." on (b)(6) 2019 - patient was diagnosed with recurrent ventral hernia thereby underwent open repair with partial excision of ventralight st (device 3).Per op notes, "the mesh was opened in the midline.Some adhesions of old mesh (device 3) were taken down.Lateral side of the mesh was intact.The medial aspect of mesh excised and removed.The defect was reapproximated with old mesh and sutured." on (b)(6) 2020 - patient was diagnosed with recurrent incisional hernia and adhesions thereby underwent repair with excision of ventralight st (device 3), lysis of adhesions and implant of bard soft mesh (device 4).(note: there is no operative notes provided for this procedure in medical records).
Additional Manufacturer Narrative
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-2015) is considered to be a best estimate.This emdr represents the ventralight st mesh (device 3).Additional supplemental emdrs were submitted to represent the ventrio st mesh (device 1) and bard flat 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 ; 8005566756
• MDR Report Key: 25299238
• Report Number: 1213643-2026-00677
• Device Sequence Number: 18470195
• Product Code: FTL
• UDI-Device Identifier: 00801741031656
• UDI-Public: (01)00801741031656(17)170328(10)HUZC0213
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K101851
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: Other,Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 05/21/2026

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: 03/28/2017
• Device Catalogue Number: 5954680
• Device Lot Number: HUZC0213
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/13/2026
• Initial Report FDA Received Date: 05/27/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/15/2015
• 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
• Patient Age: 55 YR
• Patient Sex: Male