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

Catalog Number	0010212
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Codes	Adhesion(s) (1695); Hernia (2240)
Date of Event	02/19/2019
Type of Reportable Event	Serious Injury
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-dec-2013) is considered to be a best estimate.This mdr represents the ventrio mesh (device 2).An additional supplemental emdr was submitted to represent the ventralight st using echo ps (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.
Event or Problem Description
Per information provided: on (b)(6) 2015 ¿ patient was diagnosed with ventral incisional hernia thereby underwent laparoscopic repair with the implant of ventralight st mesh using echo ps (device 1).Per op notes, ¿the patient was noted to have omental adhesion into the infraumbilical midline hernia.An ventralight st mesh echo ps (device 1) was placed into abdominal cavity and tacked.¿ on (b)(6) 2015 ¿ patient was diagnosed with recurrent ventral incisional hernia thereby underwent open repair with the partial removal of mesh (device 1).Per op notes, ¿the hernia sac and was freed up from the surrounding tissues at lower midline incision.Prior laparoscopic mesh (device 1) was trimmed.A ventrio mesh (device 2) was placed into abdominal cavity using tacks.¿ on (b)(6) 2019 ¿ patient was diagnosed with incisional hernia thereby underwent laparoscopic repair.Per op notes, ¿adhesions of omentum and small bowel up to abdominal wall and previous hernia mesh.Two pieces of mesh (device 1, 2) were noted in lower midline and right lower quadrant.The small bowel herniated between the meshes.The ileostomy site hernia mesh (device 1) had eventrated somewhat up into hernia sac and lower midline mesh (device 2) was separated from peritoneum.The mesh (device 1, 2) were tacked back together to cover the defect.¿.

• Brand Name: VENTRIO 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: 24466602
• Report Number: 1213643-2026-00247
• Device Sequence Number: 21397945
• Product Code: FTL
• UDI-Device Identifier: 00801741016394
• UDI-Public: (01)00801741016394(17)161228(10)HUXL0813
• Combination Product (Y/N): N
• Initial Reporter State: AL
• Initial Reporter Country: US
• PMA/510(K) Number: K100229
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2015
• Reporter Type: Manufacturer
• Report Source: Other,Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 02/16/2026

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: 12/28/2016
• Device Catalogue Number: 0010212
• Device Lot Number: HUXL0813
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/04/2026
• Initial Report FDA Received Date: 02/27/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 12/15/2013
• 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: 68 YR
• Patient Sex: Female