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

Catalog Number	0010212
Medical Device Problem Code	Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/13/2009
Type of Reportable Event	Malfunction
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 emdr represents the bard ventrio mesh (device 1).An additional supplemental emdr was submitted to represent the bard ventrio mesh (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) 2009 ¿ patient was diagnosed with incarcerated recurrent umbilical hernia thereby underwent laparoscopic to open repair with the implant of ventrio mesh (device # 2).Per operative notes, ¿a ventrio mesh (device 1) was rolled and attempted to be placed through a 12 mm trocar.With stay sutures and usage of the endostapler, there was difficulty in positioning the mesh, at this time created a tear in the mesh exposing polypropylene.At this time, the laparoscopic procedure was terminated, feeling that the exposed mesh has possibilities of adhesion, fistula formation, as such mesh (device #1) was removed.The procedure was converted to an open procedure, going through the midline.Then another ventrio mesh (device 2) was placed to the defect and tacked circumferentially.¿ on (b)(6) 2017 ¿ patient was diagnosed with the enterocutaneous fistula thereby underwent removal of infected mesh (device 2).Per operative notes, ¿a bowel with infected mesh (device 2) and fistula site was identified.Adhesions were lysed.The mesh (device 2) was excised and the small bowel resection performed.¿ note: this file represents device 1 which, per the medical records, during the (b)(6) 2009 procedure tore during attempted implant, therefore another mesh was implanted.

• 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: 22975578
• Report Number: 1213643-2025-00814
• Device Sequence Number: 8937791
• Product Code: FTL
• UDI-Device Identifier: 00801741016394
• UDI-Public: (01)00801741016394(10)DASK0013
• Combination Product (Y/N): N
• Initial Reporter State: CO
• Initial Reporter Country: US
• PMA/510(K) Number: K100229
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 09/03/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 0010212
• Device Lot Number: DASK0013
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/14/2025
• Initial Report FDA Received Date: 09/05/2025
• 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: Other
• Patient Age: 39 YR
• Patient Sex: Male