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 Codes	Adhesion(s) (1695); Hernia (2240)
Date of Event	10/13/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
Per information provided: (b)(6) 2013 ¿ patient was diagnosed with umbilical hernia thereby underwent open repair with implant of ventralex mesh (device #1).Per operative notes, ¿the hernia sac was identified and dissected.A ventralex mesh (device #1) was placed over the fascial defect and sutured.¿ (b)(6) 2019 ¿ patient was diagnosed with recurrent umbilical hernia thereby underwent laparoscopic repair with removal of ventralex mesh (device #1) and implant of ventralex st mesh (device #2).Per operative notes, ¿in the left upper quadrant, adherent omental tissues were removed.The mesh (device #1) was seen dislodged from the implant site.The mesh (device #1) was resected and sutured.A large ventralex st mesh (device #2) was placed over the defect in the abdominal wall and tacked.¿ (b)(6) 2021 ¿ patient was diagnosed with recurrent ventral hernia thereby underwent laparoscopic converted to open repair with implant of ventralex st mesh (device #3).Per operative notes, ¿adhesions were removed.Recurrent hernia defect was noted and removed.The mesh (device #2) was intact with tacks.A large ventralex st mesh (device #3) was placed over the hernia defect and sutured and tacked.
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-aug-2019) is considered to be a best estimate.This emdr represents the bard ventralex st (device #2).An additional supplemental emdr was submitted to represent the bard mesh - ventralex (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.

• 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: 22528821
• Report Number: 1213643-2025-00642
• Device Sequence Number: 7425592
• Product Code: FTL
• UDI-Device Identifier: 00801741031496
• UDI-Public: (01)00801741031496(17)210728(10)HUDV0585
• Combination Product (Y/N): N
• Initial Reporter State: NY
• 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): 07/07/2025

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: 07/28/2021
• Device Catalogue Number: 5950009
• Device Lot Number: HUDV0585
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/26/2025
• Initial Report FDA Received Date: 07/17/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/15/2019
• 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: 66 YR
• Patient Sex: Male