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

Catalog Number	5950007
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Codes	Adhesion(s) (1695); Hernia (2240)
Date of Event	07/10/2013
Type of Reportable Event	Serious Injury
Event or Problem Description
Per information provided: on (b)(6) 2013 - patient was diagnosed with ventral hernia (x3) thereby underwent laparoscopic repair with the implant of two ventralex st mesh (device 1 and 2) and ventrio st mesh (device 3).Per op notes, "a ventralex st patch (device 1) was placed within the abdominal cavity.Attention on the umbilical hernia, a ventralex st mesh (device 2) and ventrio st mesh (device 3) both were placed through the umbilical incision." on (b)(6) 2013 - patient was diagnosed with recurrent incisional hernia thereby underwent repair with removal of old piece of mesh (device 1, 2 and 3).Per op notes, "encountered a sac which was dissected free back to the area of the mesh that had pulled away from the fascia.Taken down the adhesions from the undersurface of the mesh and then remove this old piece of mesh (device 1, 2 and 3).Then placed an unknown onlay mesh of marlex." on (b)(6) 2013 - patient had hematoma thereby underwent evacuation of abdominal wall hematoma.Per op notes, "patient had a hematoma overlying the mesh, evacuated the hematoma.".
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-feb-2013) is considered to be a best estimate.This mdr represents the ventralex st mesh (device 2).Additional supplemental emdr's were submitted to represent the ventralex st mesh (device 1), ventrio st mesh (device 3).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: 24321412
• Report Number: 1213643-2026-00114
• Device Sequence Number: 21310267
• Product Code: FTL
• UDI-Device Identifier: 00801741031472
• UDI-Public: (01)00801741031472(17)150228(10)HUXB1482
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K101928
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2013
• Device Explanted Year: 2013
• Reporter Type: Manufacturer
• Report Source: Other,Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 02/02/2026

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: 02/28/2015
• Device Catalogue Number: 5950007
• Device Lot Number: HUXB1482
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/23/2026
• Initial Report FDA Received Date: 02/12/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/15/2013
• 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: 60 YR
• Patient Sex: Male