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

Catalog Number	5950040
Medical Device Problem Code	Patient-Device Incompatibility (2682)
Health Effect - Clinical Codes	Adhesion(s) (1695); Hernia (2240)
Date of Event	01/06/2014
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 ventralex st mesh (device 1).Note, the manufacturing date (15-mar-2013) 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: (b)(6) 2013- patient was diagnosed with recurrent incisional hernia and spigelian hernia, thereby underwent laparoscopic repair with implant of ventralex st mesh (device 1), ventrio st mesh (device 2).Per op notes, ¿hernia sac with omentum was identified in the abdominal region and the omentum was reduced.Previous mesh and tacks were found in lower midline hernia repair.A ventralex st mesh (device 1) was placed over the defect in lower midline and tacked.A ventrio st mesh (device 2) was placed over the recurrent incisional hernia on the left upper quadrant and tacked¿.(note: the previous mesh noticed in this procedure was unknown).(b)(6) 2014- patient was diagnosed with recurrent incisional hernia, thereby underwent laparoscopic repair with explant of ventrio st mesh (device 2), implant ventralight st mesh (device 3).Per op notes, ¿midline hernia healed well.Midline hernia repair mesh (device 1) was in good position.Adhesions were taken down and left flank hernia was identified and the old mesh (device 2) was excised.A ventralight st mesh (device 3) was placed in the abdomen covering the entire defect and sutured¿.

• 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: 25025883
• Report Number: 1213643-2026-00570
• Device Sequence Number: 10126839
• Product Code: FTL
• UDI-Device Identifier: 00801741031533
• UDI-Public: (01)00801741031533(17)150328(10)HUXC1095
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• PMA/510(K) Number: K101920
• 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
• Report Date (Section B): 04/22/2026

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: 03/28/2015
• Device Catalogue Number: 5950040
• Device Lot Number: HUXC1095
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/15/2026
• Initial Report FDA Received Date: 04/29/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/15/2013
• 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
• Patient Weight: 77 KG