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); Obstruction/Occlusion (2422)
Date of Event	12/29/2020
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-jul-2019) is considered to be a best estimate.This emdr was submitted to represent the bard/davol ventralex st (device #2).Additional supplemental emdr represents the bard/davol 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.
Event or Problem Description
Per information provided: (b)(6) 2014 - patient was diagnosed with painful umbilical hernia with obstruction or gangrene thereby underwent open repair with the implant of ventralex mesh (device #1).Per operative notes, ¿hernia sac was dissected.A ventralex mesh (device #1) was placed and secure it with suture.¿ (b)(6) 2020 - patient was diagnosed with incisional hernia upper midline, adhesions thereby underwent open repair with lysis of adhesion and explant of ventralex mesh (device #1) and implant of ventralex st mesh (device #2).Per operative notes, ¿adhesions were taken down.Old ventralex mesh (device #1) was completely removed.The wound was irrigated.A ventralex st mesh (device #2) was placed and sutured.¿ (b)(6) 2020 - patient was diagnosed with incisional hernia with obstruction, adhesions thereby underwent laparoscopic repair with lysis of adhesion explant of ventralex st mesh (device #2) and implant one bard soft mesh (device #3).Per operative notes, ¿midline adhesions were taken down.Old ventralex st mesh (device #2) was removed.A bard soft mesh (device #3) was placed and secure it with suture.¿.

• 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: 22737044
• Report Number: 1213643-2025-00732
• Device Sequence Number: 9306437
• Product Code: FTL
• UDI-Device Identifier: 00801741031496
• UDI-Public: (01)00801741031496(17)210728(10)HUDU1955
• 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: 2020
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: Other,Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 07/31/2025

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: HUDU1955
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/15/2025
• Initial Report FDA Received Date: 08/07/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/15/2019
• 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: 55 YR
• Patient Sex: Female