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); Pain (1994); Hernia (2240)
Date of Event	08/19/2019
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-may-2016) is considered to be a best estimate.This mdr represents the ventralex st mesh (device 2).An additional supplemental emdr was submitted to represent the composix kugel mesh (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) 2009- patient was diagnosed with incarcerated ventral hernia thereby underwent open repair with implant of composix kugel mesh (device 1).Per op notes, ¿the hernia sac was identified in the supraumbilical region and was dissected.A composix kugel mesh (device 1) was placed and sutured¿.(b)(6) 2017- patient was diagnosed with recurrent epigastric umbilical incisional hernia, thereby underwent laparoscopic repair converted to open repair with explant of composix kugel mesh (device 1), implant of ventralex st mesh (device 2).Per op notes, ¿adhesions of the omentum with the mesh was lysed and the mesh was excised.The hernia defect was identified superiorly.A ventralex st mesh (device 2) was placed and sutured¿.(b)(6) 2019- patient was diagnosed with incarcerated incisional hernia, pain, thereby underwent robotic assisted laparoscopic repair with implant of ventralight st mesh (device 3).Per op notes, ¿adhesions of the omentum to the old mesh was identified and the adhesions were lysed.The omentum tethered to the hernia located below the previously placed mesh (device 2).The omentum was reduced.The hernia defect was dissected and a ventralight st mesh (device 3) was placed in the abdominal region and sutured.¿.

• 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: 24377144
• Report Number: 1213643-2026-00165
• Device Sequence Number: 5650010
• Product Code: FTL
• UDI-Device Identifier: 00801741031496
• UDI-Public: (01)00801741031496(17)180628(10)HUAS1639
• 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: 2017
• Reporter Type: Manufacturer
• Report Source: Other,Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 02/06/2026

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: 06/28/2018
• Device Catalogue Number: 5950009
• Device Lot Number: HUAS1639
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/28/2026
• Initial Report FDA Received Date: 02/18/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/15/2016
• 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: 43 YR
• Patient Sex: Male
• Patient Weight: 107 KG