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

Catalog Number	5950050
Medical Device Problem Code	Device Appears to Trigger Rejection (1524)
Health Effect - Clinical Codes	Adhesion(s) (1695); Obstruction/Occlusion (2422)
Date of Event	12/29/2017
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-may-2016) is considered to be a best estimate.This mdr represents the ventrio st mesh (device 2).An additional supplemental emdr was submitted to represent the 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.
Event or Problem Description
Per information provided: (b)(6) 2008- patient was diagnosed with recurrent ventral incisional hernia, thereby underwent laparoscopic repair with implant of sepramesh ip (device 1).Per op notes, ¿a small hernia defect was identified in the abdominal region and was dissected.A sepramesh ip (device 1) was placed on the peritoneal space and sutured¿.(b)(6) 2017- patient was diagnosed with recurrent ventral hernia, thereby underwent laparoscopic repair with explant of sepramesh ip (device 1), implant of ventrio st mesh (device 2).Per op notes, ¿multiple adhesions of the small bowel to the underside of the sepramesh ip (device 1) in addition to omentum.Once the adhesions were lysed.The sepramesh ip (device 1) was completely explanted.A ventrio st mesh (device 2) was placed and tacked circumfascially¿.(b)(6) 2017- patient was diagnosed with small bowel obstruction, thereby underwent laparoscopic repair with implant of ventralight st using echo ps (device 3).Per op notes, ¿a portion of omentum found adhered to the previously placed mesh (device 2).A small portion of omentum had herniated underneath and a small area of omentum found protruding through the mesh (device 2).A ventralight st using echo ps (device 3) was placed and tacked.¿.

• Brand Name: VENTRIO ST
• 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: 24543509
• Report Number: 1213643-2026-00297
• Device Sequence Number: 5597164
• Product Code: FTL
• UDI-Device Identifier: 00801741031540
• UDI-Public: (01)00801741031540(17)180628(10)HUAS2123
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• PMA/510(K) Number: K101920
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: Other,Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 03/04/2026

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: 06/28/2018
• Device Catalogue Number: 5950050
• Device Lot Number: HUAS2123
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/20/2026
• Initial Report FDA Received Date: 03/09/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/15/2016
• 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: 57 YR
• Patient Sex: Male