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

Catalog Number	0010301
Medical Device Problem Code	Patient-Device Incompatibility (2682)
Health Effect - Clinical Codes	Abdominal Pain (1685); Adhesion(s) (1695); Inflammation (1932); Hernia (2240)
Date of Event	01/01/2015
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-2007) is considered to be a best estimate.This mdr represents the ventralex mesh (device 2).An additional supplemental emdr was submitted to represent the ventralex mesh (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: on (b)(6) 2007 - patient was diagnosed with umbilical and epigastric hernia thereby underwent open repair with implant of ventralex mesh (device 1 and 2).Per op notes, ¿two hernias were identified, umbilical hernia and epigastric hernia.The defect was noted to be above the umbilicus and one in the right of umbilicus.The hernia sac and contents were excised.The ventral hernial defect was repaired with ventralex mesh (device 1) and epigastric hernia was repaired with ventralex mesh (device 2).The original defect was also closed with mayo technique¿ on (b)(6) 2011 ¿ patient was diagnosed with suprapubic recurrent ventral hernia thereby underwent open repair with implant of synthetic mesh and biological mesh.Per op notes, ¿the recurrent defect was noted to be bulging.An elliptical incision was made along the old suprapubic and towards the right sided incision.Scar tissue was then excised.The hernia was identified.A synthetic mesh was placed in the intraperitoneal space and secured to the anterior abdominal wall with sutures.A biological mesh was then placed through the top of the connective tissue and secured." on (b)(6) 2015 - patient was diagnosed with incarcerated recurrent incisional hernia thereby underwent open repair with excision of ventralex mesh (device 1 and 2).Per op notes, ¿a lower midline incision was made.An incarcerated intra-abdominal fat which had necrosed was noted.The old mesh (device 1 and 2) against the bowel was noted to be free.The mesh (device 1 and 2) were removed.The small bowel adhesions were taken down around the hernia repair.The defect was closed primarily with sutures.¿.

• 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: 24481606
• Report Number: 1213643-2026-00260
• Device Sequence Number: 9581541
• Product Code: FTL
• UDI-Device Identifier: 00801741000355
• UDI-Public: (01)00801741000355(10)HURC8840
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K132441
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2007
• Device Explanted Year: 2015
• Reporter Type: Manufacturer
• Report Source: Other,Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 02/25/2026

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 Catalogue Number: 0010301
• Device Lot Number: HURC8840
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/10/2026
• Initial Report FDA Received Date: 03/02/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/15/2007
• 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: 61 YR
• Patient Sex: Female
• Patient Weight: 119 KG