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	Inflammation (1932); Pain (1994); Hernia (2240)
Date of Event	06/16/2016
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-sep-2015) is considered to be a best estimate.This mdr represents the ventralex st mesh (device 1).An additional supplemental emdr was submitted to represent the ventrio st mesh (device 2).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: on (b)(6) 2015 ¿ patient was diagnosed with incarcerated recurrent umbilical hernia thereby underwent open repair with implant of ventralex st mesh (device 1).Per operative notes, ¿a recurrent incarcerated umbilical hernia with sac was identified and dissected off.A ventralex st mesh (device 1) was placed subfascially and sutured in four quadrants.The fascia was closed and secured with sutures.¿ on (b)(6) 2016 ¿ patient was diagnosed with recurrent umbilical hernia and pain thereby underwent laparoscopic repair with removal of ventralex st mesh (device 1) and implant of ventrio st mesh (device 2).Per operative notes, ¿the prior mesh (device 1) with inflammatory tissues were excised.The recurrent defect was closed and ventrio st mesh (device 2) was placed over the defect tacked and sutured in place.¿ on (b)(6) 2019 - patient was diagnosed with recurrent incarcerated umbilical hernia and pain thereby underwent open repair with removal of old mesh (device 2) and primary repair of incarcerated umbilical hernia.Per operative notes, ¿in the periumbilical region, a palpable hernia with sac was noted.A large defect just above the umbilicus and smaller defect at the base of the umbilicus was dissected free circumferentially down to the fascia.A round piece of mesh (device 2) attached to the midline fascia was removed.The defects were connected together and closed primarily with sutures.Extensive dense adhesions to anterior abdominal wall and omentum and scar tissues were removed.The fascia was closed and secured with sutures circumferentially.The wound was irrigated and reapproximated with sutures.¿.

• 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: 24377153
• Report Number: 1213643-2026-00162
• Device Sequence Number: 17555207
• Product Code: FTL
• UDI-Device Identifier: 00801741031496
• UDI-Public: (01)00801741031496(17)171128(10)HUZI1229
• 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: 2015
• Device Explanted Year: 2016
• 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: 11/28/2017
• Device Catalogue Number: 5950009
• Device Lot Number: HUZI1229
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/30/2026
• Initial Report FDA Received Date: 02/18/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/15/2015
• 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: 36 YR
• Patient Sex: Female