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 Code	Seroma (2069)
Date of Event	08/12/2015
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-2012) is considered to be a best estimate.This mdr represents the ventrio st (device #2).An additional supplemental emdr was submitted to represent the ventralight st (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) 2013: patient was diagnosed with recurrent incisional incarcerated hernia thereby underwent open repair with implant of ventralight st (device #1).Per operative notes, ¿a ventralight st (device #1) was placed in upper abdominal wall and sutured.¿ on (b)(6) 2013: patient was diagnosed with large left abdominal wall mass, seroma and recurrent incarcerated incisional hernia thereby underwent open repair with implant of ventrio st (device #2).Per operative notes, ¿adhesions were taken down.Scar tissue was noted and the capsule was resected.The prior hernia mesh was encountered (device #1).A ventrio st mesh (device #2) was placed and sutured.¿ on (b)(6) 2015: patient was diagnosed with abdominal mass thereby underwent open repair with implant of phasix flat mesh (device #3).Per operative notes, ¿a large volume of fluid was drained.The seroma capsule was removed.A phasix flat mesh (device #3) was placed in the abdominal wall and iliac crest using protacks.¿.

• 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: 22725212
• Report Number: 1213643-2025-00729
• Device Sequence Number: 8288415
• Product Code: FTL
• UDI-Device Identifier: 00801741031526
• UDI-Public: (01)00801741031526(17)140828(10)HUWH1071
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K101920
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2013
• Reporter Type: Manufacturer
• Report Source: Other,Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 08/01/2025

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: 08/28/2014
• Device Catalogue Number: 5950030
• Device Lot Number: HUWH1071
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/16/2025
• Initial Report FDA Received Date: 08/06/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/15/2012
• 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: 69 YR
• Patient Sex: Male