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

Catalog Number	0010301
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Codes	Adhesion(s) (1695); Hernia (2240)
Date of Event	03/11/2010
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-dec-2008) is considered to be a best estimate.This emdr represents the ventralex mesh (device 1).An additional supplemental emdr was submitted to represent the mesh - ventralex (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) 2008 ¿ patient was diagnosed with incisional hernia thereby underwent open repair with implant of ventralex mesh (device 1).Per operative notes, ¿an incisional hernia at the mid to upper portion of his midline incision was dissected.Sac with adhesions were lysed and small ventralex mesh (device 1) was placed and sutured to the fascial defect.On (b)(6) 2009 ¿ patient was diagnosed with recurrent incisional hernia and migrated mesh thereby underwent open repair with implant of small ventralex mesh (device 2).Per operative notes, ¿an incisional hernia just above the previous incision and two small incisional hernia just beneath the previous incision was noted.The sac was reduced, and part of old mesh was seen pulled away from the fascia.The mesh was grasped and sutured to the fascia and defect was closed with sutures.Another defect in the right and left side was noted.On the right side, the defect was reduced and fascia was closed with sutures.In left side defect, fascia was removed and small ventralex mesh (device 2) was sutured to the fascia and old mesh.(device 1)¿.On (b)(6) 2010 ¿ patient was diagnosed with recurrent incisional hernia thereby underwent laparoscopic repair with implant of sepramesh ip (device 3).Per operative notes, ¿a recurrent hernia in the upper part of the incision and one just to right of the umbilicus was noted.Adhesions were removed and previously placed meshes (device 1 and 2) were noted and left intact.The multiple incisional hernias including previous incisional hernias were closed with tacks and sepramesh ip (device 3) was placed and sutured.¿.

• 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 ; 8005566756
• MDR Report Key: 23670868
• Report Number: 1213643-2025-01151
• Device Sequence Number: 15879918
• Product Code: FTL
• UDI-Device Identifier: 00801741000355
• UDI-Public: (01)00801741000355(17)131228(10)HUSL0097
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K132441
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2008
• Reporter Type: Manufacturer
• Report Source: Other,Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 11/26/2025

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: 12/28/2013
• Device Catalogue Number: 0010301
• Device Lot Number: HUSL0097
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/06/2025
• Initial Report FDA Received Date: 11/28/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 12/15/2008
• 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: 55 YR
• Patient Sex: Male