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

Catalog Number	5950009
Medical Device Problem Code	Patient-Device Incompatibility (2682)
Health Effect - Clinical Code	Adhesion(s) (1695)
Date of Event	10/22/2019
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-2018) is considered to be a best estimate.This mdr represents the ventralex st mesh (device 3).Additional supplemental emdr's were submitted to represent the ventrio st mesh (device 1), ventrio st 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.
Event or Problem Description
Per informed provided: 08-apr-2014 - patient was diagnosed with incisional hernia thereby underwent open repair with implant of ventrio st mesh (device 1).Per operative notes, ¿a midline incision was made.The hernia sac was dissected out.A ventrio st mesh (device 1) was placed in the perifascial region and was sutured in placed with several surgilon sutures.¿ (b)(6) 2016 - patient was diagnosed with recurrent incisional hernia thereby underwent open repair with implant of ventrio st mesh (device 2).Per operative notes, ¿an elliptical skin incision was made around the previous scar and umbilicus.The hernia sac was dissected out.A ventrio st mesh (device 2) was placed into the defect and secure it with sutures.¿ (b)(6) 2019 - patient was diagnosed with incisional hernia, adhesion thereby underwent open repair with implant of ventralex st mesh (device 3).Per operative notes, ¿linear incision was made.The hernia sac was dissected out.Lysis of adhesion was performed.A ventralex st mesh (device 3) was placed into the defect and closed with sutures.¿ (b)(6) 2019 - patient was diagnosed with adhesion thereby underwent repair with lysis of adhesion.Per operative notes, ¿previously placed mesh was well incorporated but heavily adherent to the small bowel.Lysis of adhesion was performed.¿.

• Brand Name: VENTRALEX 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: 23775511
• Report Number: 1213643-2025-01181
• Device Sequence Number: 10079296
• Product Code: FTL
• UDI-Device Identifier: 00801741031496
• UDI-Public: (01)00801741031496(17)210128(10)HUCZ0770
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: K101928
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: Other,Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 12/08/2025

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: 01/28/2021
• Device Catalogue Number: 5950009
• Device Lot Number: HUCZ0770
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/17/2025
• Initial Report FDA Received Date: 12/11/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 12/15/2018
• 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: 64 YR
• Patient Sex: Female