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

Catalog Number	5950007
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Codes	Adhesion(s) (1695); Pain (1994); Hernia (2240)
Date of Event	04/17/2015
Type of Reportable Event	Serious Injury
Event or Problem Description
Per information provided: on (b)(6) 2013 - patient was diagnosed with incisional hernia thereby underwent open repair with implant of ventralex st (device #1).Per op notes, ¿the hernia sac was identified and dissected.The sac was opened, and the omentum was reduced.The sac was reduced.The old mesh was identified near omentum.A ventralex st (device #1) was placed and sutured.¿ (note: the old mesh mentioned in this procedure was unknown) on (b)(6) 2013 - patient was diagnosed with recurrent incisional hernia thereby underwent open repair with implant of ventralex st (device #2).Per op notes, ¿the prior mesh (device #1) was fine and intact.The hernia sac was identified lateral left side of prior mesh.The sac contains peritoneal fat.The fat and hernia sac were reduced.A ventralex st (device #2) was placed and sutured.¿ on (b)(6) 2015 - patient was diagnosed with recurrent incisional ventral hernia with pain thereby underwent laparoscopic repair with implant of ventralight st (device #3).Per op notes, ¿the omental adhesions were taken down.The two pieces of mesh (device #1 and #2) were identified and appeared to be wadded.Both meshes (device #1 and #2) adherent to omentum were taken down.The wadded mesh was tacked back.The hernia defect was identified and reduced.A ventralight st (device #3) was placed and tacked.¿.
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-2013) is considered to be a best estimate.This emdr was submitted to represent the bard/davol ventralex st (device #2).Additional supplemental emdr represents the bard/davol 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.

• 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: 22713666
• Report Number: 1213643-2025-00715
• Device Sequence Number: 9923955
• Product Code: FTL
• UDI-Device Identifier: 00801741031472
• UDI-Public: (01)00801741031472(17)150928(10)HUXI0773
• 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
• Reporter Type: Manufacturer
• Report Source: Other,Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 07/31/2025

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: 09/28/2015
• Device Catalogue Number: 5950007
• Device Lot Number: HUXI0773
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/16/2025
• Initial Report FDA Received Date: 08/05/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/15/2013
• 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: 50 YR
• Patient Sex: Male