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

Catalog Number	5950007
Medical Device Problem Code	Patient-Device Incompatibility (2682)
Health Effect - Clinical Codes	Adhesion(s) (1695); Bowel Perforation (2668)
Date of Event	02/15/2019
Type of Reportable Event	Serious Injury
Event or Problem Description
Per information provided: on (b)(6) 2008 - patient was diagnosed with symptomatic umbilical hernia thereby underwent open repair with implant of ventralex mesh (device #1).Per op notes, "a ventralex mesh (device #1) was placed and sutured." on (b)(6) 2011 - patient was diagnosed with adhesions, right adnexal pain thereby underwent laparoscopic lysis of adhesions.On (b)(6) 2014 - patient was diagnosed with adhesions thereby underwent laparoscopic lysis of adhesions.On (b)(6) 2017 - patient was diagnosed with recurrent periumbilical incisional hernia thereby underwent open repair with implant of ventralex st mesh (device #2).Per op notes, "a ventralex st mesh (device #2) was placed and sutured." on (b)(6) 2019 - patient was diagnosed with sigmoid diverticulitis with micro perforation thereby underwent removal of old mesh (device #1 & #2).Per op notes, "adhesions were taken down.The folded meshes (device #1 & #2) were removed." on (b)(6) 2019 - patient diagnosed with recurrent incisional hernia thereby underwent open repair with implant of ventralight st mesh (device #3).Per op notes, "lysis of adhesions was preformed and a ventralight st mesh (device #3) was placed and sutured.".
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-jun-2017) is considered to be a best estimate.This emdr represents the bard/davol ventralex st (device #2).Additional supplemental emdr was submitted to represent 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.

• Brand Name: VENTRALEX
• 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: 22338375
• Report Number: 1213643-2025-00525
• Device Sequence Number: 18423437
• Product Code: FTL
• UDI-Device Identifier: 00801741031472
• UDI-Public: (01)00801741031472(17)190728(10)HUBT2134
• Combination Product (Y/N): N
• Initial Reporter State: RI
• Initial Reporter Country: US
• PMA/510(K) Number: K101928
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: Other,Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 06/10/2025

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: 07/28/2019
• Device Catalogue Number: 5950007
• Device Lot Number: HUBT2134
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/03/2025
• Initial Report FDA Received Date: 06/26/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/15/2017
• 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; Life Threatening
• Patient Age: 39 YR
• Patient Sex: Female