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

Catalog Number	5950070
Medical Device Problem Codes	Defective Device (2588); Patient Device Interaction Problem (4001)
Health Effect - Clinical Codes	Abdominal Pain (1685); Hematoma (1884); Seroma (2069)
Date of Event	07/29/2014
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Based on the information available, no conclusion can be made.Per medical records review, about 3 months post implant of ventrio st mesh, patient was diagnosed with seroma, hematoma and abdominal pain thereby underwent repair.The instructions-for-use supplied with the device lists seroma and hematomas as possible complications.This emdr is submitted to represents ventrio st mesh (device #2).An additional supplemental emdr is submitted to represent composix kugel mesh (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 by the attorney: on (b)(6) 2012 - patient with the history of primary umbilical hernia repair developed recurrent incisional hernia thereby underwent open repair with the implant of composix kugel (device #1).Per operative notes, "the hernia sac was identified just inferior to the umbilicus and amputated.A piece of composix kugel mesh (device #1) was irrigated in antibiotic solution and secured in place with suture." 07-apr-2014 - patient developed abdominal pain, abdominal distention, lightheaded, nausea and vomiting thereby underwent ct scan.On (b)(6) 2014 - patient was diagnosed with large incisional hernia thereby underwent laparoscopic repair with ventrio st mesh (device #2), iysis of adhesions and removal of mesh (device #1).Per operative notes, ¿there was a large incisional hernia and a large hernia sac which contained old mesh.There was a dense adhesion of the omentum to the mesh, and a segment of the small bowel was also adhered to the mesh which were taken down with sharp dissection.The small bowel was freed and hernia sac was then excised.A ventrio st mesh (device #2) was then placed into the abdominal cavity and tacked.¿ 29-jul-2014 - patient was diagnosed with abdominal pain thereby underwent evacuation of seroma and hematoma.Per operative notes, ¿the capsule surrounding the seroma/hematoma was excised.Cultures were taken from the hematoma/seroma fluid.The fascia, was intact and there was no evidence of exposure of underlying mesh.¿ 30-jul-2014 - patient had a placement of wound vac and would likely need it for long time.Attorney alleges that the patient had adhesions, mesh migration, pain, hernia recurrence and emotional injuries.

• Brand Name: VENTRIO ST
• Common Device Name: SURGICAL MESH
• Manufacturer (Section D): DAVOL INC., SUB. C.R. BARD, INC.; 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 ; 4018258495
• MDR Report Key: 19166707
• Report Number: 1213643-2024-092062
• Device Sequence Number: 20817848
• Product Code: FTL
• UDI-Device Identifier: 00801741031564
• UDI-Public: (01)00801741031564
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K101920
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2014
• Reporter Type: Manufacturer
• Report Source: Other,Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 04/23/2024

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: 11/28/2015
• Device Catalogue Number: 5950070
• Device Lot Number: HUXK0027
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/01/2024
• Initial Report FDA Received Date: 04/23/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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: 59 YR
• Patient Sex: Female
• Patient Weight: 88 KG