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	Adhesion(s) (1695); Hernia (2240); Obstruction/Occlusion (2422)
Date of Event	09/29/2015
Type of Reportable Event	Serious Injury
Event or Problem Description
Per information provided: (b)(6) 2012 ¿ patient was diagnosed with multiple incisional hernias thereby underwent open repair with the implant of ventralex st mesh (device 1, 2) and composix kugel patch (device 3).Per op notes, ¿the patient was found to have hernias at the previous ileostomy and mucus fistula sites.The median ventralex st mesh (device 1) was placed on previous mucus site in the right upper quadrant and secured using sutures.The one in right lower quadrant was repaired using a large ventralex st mesh (device 2) and sutured.The midline incisional hernia was repaired using a composix kugel mesh (device 3) was placed and secured in several different locations using sutures.¿ (b)(6) 2014 ¿ patient was diagnosed with recurrent incisional hernia thereby underwent open repair with the ventralex st mesh (device 4).Per op notes, ¿in the periumbilical region, there was a definite recurrent incisional hernia noted.Omental adhesions were taken down.The mesh (device 1, 3) was somewhat buckled, but there was no obvious tear.A large ventralex st mesh (device 4) was placed into defect and secured using sutures.¿ (b)(6) 2015 ¿ patient was diagnosed with five time recurrent incarcerated incisional hernia; small bowel stricture thereby underwent implant of bard soft mesh (device 5).Per op notes, ¿extensive adhesions to the small bowel and mesh were lysed.Loop of small bowel was incarcerated up within the hernia around the mesh reduced.The area of small bowel matted to mesentery appeared to be thickened and strictured was resected.The defect was noted.The midline lateral abdominal wall masses were removed and there was no intraperitoneal mesh.The myofascial flaps were raised on both sides.The scarred with all prior mesh was noted.The bard soft mesh (device 5) was placed in a diamond configuration using sutures.¿.
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-dec-2011) 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) and composix kugel mesh (device 3).An additional mdr was submitted to represent the ventralex st mesh (device 4).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: 24320362
• Report Number: 1213643-2026-00108
• Device Sequence Number: 10005034
• Product Code: FTL
• UDI-Device Identifier: 00801741031496
• UDI-Public: (01)00801741031496(17)131228(10)HUVL1431
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K101928
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2012
• Reporter Type: Manufacturer
• Report Source: Other,Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 02/04/2026

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: 12/28/2013
• Device Catalogue Number: 5950009
• Device Lot Number: HUVL1431
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/22/2026
• Initial Report FDA Received Date: 02/12/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 12/15/2011
• 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: Male