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

Catalog Number	0010215
Medical Device Problem Code	Patient-Device Incompatibility (2682)
Health Effect - Clinical Code	Hernia (2240)
Date of Event	04/24/2014
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.This mdr represents the ventrio mesh (device 1).An additional supplemental emdr was submitted to represent the bard ventralex st mesh (device 2).Note, the manufacturing date (15-may-2010) is considered to be a best estimate.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: (b)(6) 2011 - patient was diagnosed with incarcerated umbilical hernia thereby underwent laparoscopic repair with implant of ventrio mesh (device 1).Per operative notes, ¿an incision was made into the umbilicus.The hernia sac was dissected out.A ventrio mesh (device 1) was placed into the abdominal cavity and secure it with sutures.¿ (b)(6) 2012 ¿ patient was diagnosed with recurrent umbilical/ventral hernia, thereby underwent open repair with implant of ventralex st mesh (device 2).Per operative notes, ¿a supraumbilical curvilinear incision was made over the umbilicus.The hernia sac was dissected out.A large ventralex st mesh (device 2) was placed with previously placed old (device 1) and secured it with sutures.¿ (b)(6) 2014 - patient was diagnosed with recurrent ventral hernia, thereby underwent open repair with explant of ventrio mesh (device 1) and ventralex st mesh (device 2) and implant of biological mesh.Per operative notes, ¿an incision was made vertically in the midline above the umbilicus.The hernia sac was dissected out.The previously placed meshes were identified.Both (device 1) and (device 2) were excised entirely.A biological mesh was placed into the defect and closed the defect with sutures.¿.

• Brand Name: VENTRIO MESH
• 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: 24801208
• Report Number: 1213643-2026-00448
• Device Sequence Number: 10679201
• Product Code: FTL
• UDI-Device Identifier: 00801741016424
• UDI-Public: (01)00801741016424(17)111128(10)HUUE1116
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K100229
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2011
• Device Explanted Year: 2014
• Reporter Type: Manufacturer
• Report Source: Other,Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 04/01/2026

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: 11/28/2011
• Device Catalogue Number: 0010215
• Device Lot Number: HUUE1116
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/20/2026
• Initial Report FDA Received Date: 04/07/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/15/2010
• 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: 49 YR
• Patient Sex: Male
• Patient Weight: 138 KG