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

Catalog Number	0010302
Medical Device Problem Codes	Defective Device (2588); Patient Device Interaction Problem (4001); Migration (4003)
Health Effect - Clinical Codes	Adhesion(s) (1695); Scar Tissue (2060); Hernia (2240)
Date of Event	10/07/2014
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-2008) is considered to be a best estimate.This emdr represents the mesh ¿ ventralex (device #1).Additional supplemental emdr's were submitted to represents the ventrio st (device # 2 & #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.
Event or Problem Description
Per information provided: on (b)(6) 2011 - patient was diagnosed with incarcerated umbilical hernias thereby underwent open repair with the implant of ventralex mesh (device # 1).Per operative notes, ¿the sac was excised.A bard ventralex mesh (device #1) was inserted and placed through the strapped.¿ on (b)(6) 2014 - patient was diagnosed with incisional hernia thereby underwent open repair with the explant of previous mesh ventralex mesh (device #1) and implant of ventrio st mesh (device #2).Per operative notes, ¿the scar tissue was there about the umbilicus.The ventralex mesh had released itself from the attachment.The mesh was then removed carefully.The hernia was then easily extracted.Adhesion was taken down.A round ventrio st mesh (device # 2) was placed and sutured.¿ on (b)(6) 2015 - patient was diagnosed with recurrent ventral hernia thereby underwent open repair with the explant of ventrio st mesh (device # 2) and implant of ventrio st mesh (device #3).Per operative notes, ¿some omentum was dissected.Previously placed ventrio st mesh (device # 2) was fully removed.A ventrio st mesh (device # 3) was placed and tacked.¿.

• Brand Name: MESH ¿ 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 ; 4018258495
• MDR Report Key: 21949683
• Report Number: 1213643-2025-090190
• Device Sequence Number: 21041763
• Product Code: FTL
• UDI-Device Identifier: 00801741016479
• UDI-Public: (01)00801741016479(17)131128(10)HUSI1985
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K132441
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2011
• Device Explanted Year: 2014
• Reporter Type: Manufacturer
• Report Source: Other,Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 05/02/2025

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: 11/28/2013
• Device Catalogue Number: 0010302
• Device Lot Number: HUSI1985
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/16/2025
• Initial Report FDA Received Date: 05/02/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/15/2008
• 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: 45 YR
• Patient Sex: Male