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

Catalog Number	5950080
Medical Device Problem Code	Patient-Device Incompatibility (2682)
Health Effect - Clinical Code	Hernia (2240)
Date of Event	01/09/2014
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.This mdr represents the ventrio st mesh (device 2).An additional supplemental emdr was submitted to represent the ventralight st mesh using echo ps (device 1).Note, the manufacturing date (15-nov-2011) is considered to be a best estimate.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) 2012 - patient was diagnosed with incisional hernia thereby underwent laparoscopic repair with the implant of ventralight st mesh using echo ps (device 1).Per op notes, "a ventralight st mesh using echo ps (device 1) was placed to the umbilicus using tacks." on (b)(6) 2012 - patient was diagnosed with recurrent incisional hernia thereby underwent open repair with removal of mesh (device 1) and implant of ventrio st (device 2).Per op notes, "an upper midline incision was then made.The mesh was then opened and there was adhesions underlying the mesh, these adhesions were taken down and the mesh (device 1) was removed.A ventrio st mesh (device 2) was placed to the abdominal wall and a synthetic mesh also placed." on (b)(6) 2014 - patient was diagnosed with recurrent incisional hernia and umbilical hernia thereby underwent repair.Per op notes, "umbilical hernia was noted and above this the incisional hernia was also entered.The pannus was then removed off of the abdominal wall.The previous mesh was noted.".

• 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: 24696337
• Report Number: 1213643-2026-00373
• Device Sequence Number: 15979875
• Product Code: FTL
• UDI-Device Identifier: 00801741031571
• UDI-Public: (01)00801741031571(17)131128(10)HUVK1434
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K101920
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2012
• Reporter Type: Manufacturer
• Report Source: Other,Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 03/13/2026

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: 11/28/2013
• Device Catalogue Number: 5950080
• Device Lot Number: HUVK1434
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/06/2026
• Initial Report FDA Received Date: 03/26/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/15/2011
• 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: 33 YR
• Patient Sex: Female