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 Incompatibility (2682)
Health Effect - Clinical Codes	Pain (1994); Obstruction/Occlusion (2422)
Date of Event	09/02/2010
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Based on the additional information received, there is no change to initial determination, no conclusions can be made.Per medical records review, about 3 years 3 months post implant of ventralex mesh, patient was diagnosed with bowel obstruction and underwent medical imaging technique.Note, the event date (25-feb-2025) is considered to be a best estimate based on the awareness date.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 by patient's attorney: (b)(6) 2007 - patient was diagnosed with incarcerated umbilical hernia thereby underwent open repair with implant of ventralex mesh and partial omentectomy.Per operative notes, "the umbilical hernia sac was dissected free from subcutaneous tissue of the inferior aspect of umbilicus.The entire hernia sac was excised, and the incarcerated hernia sac was freed.The remainder omentum and preperitoneal fat were reduced.A ventralex mesh was placed into the fascial defect and sutured." (b)(6) 2010 - patient was diagnosed with small bowel obstruction.Attorney alleges that the patient had bowel obstruction, hernia recurrence and pain.

• 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: 21652365
• Report Number: 1213643-2025-00212
• Device Sequence Number: 7424577
• Product Code: FTL
• UDI-Device Identifier: 00801741016479
• UDI-Public: (01)00801741016479
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• PMA/510(K) Number: K132441
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2007
• Reporter Type: Manufacturer
• Report Source: Other,Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 02/28/2025

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 Catalogue Number: 0010302
• Device Lot Number: 43CQD575
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/25/2025
• Initial Report FDA Received Date: 03/20/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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: 53 YR
• Patient Sex: Male
• Patient Weight: 145 KG