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 Codes	Adhesion(s) (1695); Pain (1994); Hernia (2240)
Date of Event	05/24/2017
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-aug-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 underwent for incisional hernia repair with implant of ventrio mesh (device 1), reduction of incarcerated omental tissue, takes down of falciform ligament.(b)(6) 2017 - patient was diagnosed with incisional hernia recurrence, adhesions, pain and thereby underwent implant with ventralight st mesh (device 2).
Event or Problem Description
Per information provided: (b)(6) 2011 - patient was underwent for incisional hernia repair with implant of ventral mesh (device 1), reduction of incarcerated omental tissue, takes down of falciform ligament.(ppf) (b)(6) 2017 - patient was diagnosed with incisional hernia and thereby underwent implant with ventralight mesh (device 2).(ppf).Per review of medical record: (b)(6) 2011 ¿ patient was diagnosed with incarcerated incisional hernia thereby underwent laparoscopic repair with the implant of ventrio mesh (device 1).Per op notes, ¿a ventrio mesh (device 1) was placed into anterior abdominal wall using sorbafix tacks.¿ (b)(6) 2017 ¿ patient was diagnosed with recurrent incarcerated incisional hernia thereby underwent laparoscopic repair with the implant of ventralight st mesh using echo ps (device 2).Per op notes, ¿adhesions from previous repair was lysed.A hernia was identified at umbilicus.A ventralight st using echo ps (device 2) was placed into abdominal wall and tacked.¿.
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-aug-2010) is considered to be a best estimate.Addendum: h11: this supplemental emdr is submitted to update the event description and to correct the product catalog no.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: 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: 23366566
• Report Number: 1213643-2025-01021
• Device Sequence Number: 13284219
• Product Code: FTL
• UDI-Device Identifier: 00801741016448
• UDI-Public: (01)00801741016448(17)120228(10)HUUH1338
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• PMA/510(K) Number: K100229
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2011
• Reporter Type: Manufacturer
• Report Source: Other,Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/28/2025

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 Expiration Date: 02/28/2012
• Device Catalogue Number: 0010215
• Device Lot Number: HUUH1338
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/15/2025
• Supplement Date Received by Manufacturer: 10/24/2025
• Initial Report FDA Received Date: 10/23/2025
• Supplement Report FDA Received Date: 11/14/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/15/2010
• 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: 55 YR
• Patient Sex: Female