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

Catalog Number	5950010
Medical Device Problem Code	Patient Device Interaction Problem (4001)
Health Effect - Clinical Codes	Fistula (1862); Unspecified Infection (1930); Hernia (2240)
Date of Event	12/02/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
As reported, it is alleged that the patient developed fistula, hernia, unspecified infection, and surgical/medical intervention post implant of ventrio st mesh.The information provided is limited and contact information is unavailable, therefore, we are unable to request additional information.Based on the information provided, no conclusion can be made as to the degree to which the ventrio st mesh, may have caused or contributed to the patient¿s reported postoperative course.The adverse reaction section of the instructions-for-use, supplied with the device, identifies recurrence, fistula and infection as possible complications.In regards to infection, the warning section of the ifu states, "if an infection develops, treat the infection aggressively.Consideration should be given regarding the need to remove the prosthesis.An unresolved infection may require removal of the prosthesis." no lot number has been provided; therefore, a review of the manufacturing records could not be conducted.Should additional information be provided, a supplemental mdr will be submitted.
Event or Problem Description
It was reported that following implant of a ventrio st, the patient developed fistula, hernia, and unspecified infection.It was further reported that the device was explanted, and patient underwent unexpected medical intervention and additional surgery.

• 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
• MDR Report Key: 10992543
• Report Number: 1213643-2020-20076
• Device Sequence Number: 17013661
• Product Code: FTL
• UDI-Device Identifier: 00801741031502
• UDI-Public: (01)00801741031502
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K101920
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,other
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 12/04/2020

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: 5950010
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/02/2020
• Initial Report FDA Received Date: 12/11/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention