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

Catalog Number	5950008
Medical Device Problem Code	Patient-Device Incompatibility (2682)
Health Effect - Clinical Codes	Adhesion(s) (1695); Unspecified Infection (1930); Hernia (2240)
Date of Event	12/10/2018
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-mar-2017) is considered to be a best estimate.This emdr represents the bard ventralex st (device #2).An additional supplemental emdr was submitted to represent the bard ventralex st (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) 2017 - patient was diagnosed with recurrent ventral incisional hernia thereby underwent open repair with implant of ventralex st (device #1 & #2).Per op notes, ¿the hernia sac was identified and dissected free.Two ventralex st (device #1 & #2) was placed and sutured.¿ (b)(6) 2018 - patient was diagnosed with infected mesh, recurrent ventral incisional hernia and poor wound healing thereby underwent open repair with excision of ventralex st (device #1 & #2) and implant of biological mesh.Per op notes, ¿the adhesions of mesh were taken down.The infected mesh with granulation tissue was identified and excised.The hernia defect was identified and excised.A biological mesh was placed and sutured.¿ (b)(6) 2019 - patient was diagnosed with sinus granuloma of umbilicus and poor wound healing thereby underwent open repair with excision of granuloma tissue.(b)(6) 2019 - patient was diagnosed with infected synthetic mesh, recurrent ventral incisional hernia and poor wound healing thereby underwent open repair with excision of retained ventralex st (device #1 & #2) and implant of biological mesh.Per op notes, ¿the retained infected synthetic mesh (device #1 & #2) was identified and removed entirely.The mesh had been largely excised during prior surgery.The prior biological mesh was seen during this procedure was intact.The hernia defect was identified and repaired using biological mesh.¿.

• 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: 22532646
• Report Number: 1213643-2025-00649
• Device Sequence Number: 7425320
• Product Code: FTL
• UDI-Device Identifier: 00801741031489
• UDI-Public: (01)00801741031489(17)190528(10)HUBQ0991
• Combination Product (Y/N): N
• Initial Reporter State: TN
• 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: 2018
• Reporter Type: Manufacturer
• Report Source: Other,Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 07/07/2025

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: 05/28/2019
• Device Catalogue Number: 5950008
• Device Lot Number: HUBQ0991
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/25/2025
• Initial Report FDA Received Date: 07/17/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/15/2017
• 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
• Patient Age: 44 YR
• Patient Sex: Female