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

Catalog Number	5950030
Medical Device Problem Code	Patient-Device Incompatibility (2682)
Health Effect - Clinical Codes	Adhesion(s) (1695); Hernia (2240)
Date of Event	02/26/2018
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 emdr represents the ventrio st (device #2).An additional supplemental emdr was submitted to represent the parastomal patch (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) 2012: patient was diagnosed with parastomal hernia thereby underwent open repair with implant of parastomal patch (device #1).Per operative notes, ¿multiple intra-abdominal adhesions were taken down.The parastomal hernia was noted and repaired with parastomal patch (device #1) within the abdomen and sutured.¿ on (b)(6) 2013: patient was diagnosed with recurrent incarcerated parastomal hernia thereby underwent open repair with implant of ventrio st (device #2).Per operative notes, ¿the extensive intraabdominal adhesions were dissected.The parastomal hernia was noted around previously placed mesh (device #1).The hernia was repaired and placed with ventrio st (device #2).On (b)(6) 2018: patient was diagnosed with recurrent parastomal hernia and ventral hernia thereby underwent open repair with removal of mesh.Per operative notes, ¿multiple ventral hernia were encountered and dense adhesions in the abdomen and mesh were removed.(device #1 and device #2).The parastomal hernia and ventral hernia were closed with sutures.¿ on (b)(6) 2019: patient was diagnosed with ventral hernia and incisional hernia and abdominal pain thereby underwent open repair with implant of bard flat mesh (device #3) and phasix mesh (device #4).Per operative notes, ¿the large defect in the periumbilical area and several small defects were identified.The large bard flat mesh (device #3) was placed and secured with sutures.To the anterior fascia the phasix mesh (device #4) was placed and secured.¿.

• Brand Name: VENTRIO ST
• 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: 22122041
• Report Number: 1213643-2025-00420
• Device Sequence Number: 17206214
• Product Code: FTL
• UDI-Device Identifier: 00801741031526
• UDI-Public: (01)00801741031526
• Combination Product (Y/N): N
• Initial Reporter State: RI
• Initial Reporter Country: US
• PMA/510(K) Number: K101920
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2013
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: Other,Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 05/23/2025

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: 5950030
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/14/2025
• Initial Report FDA Received Date: 06/02/2025
• 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: 55 YR
• Patient Sex: Female
• Patient Weight: 78 KG