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

Catalog Number	5950050
Medical Device Problem Code	Patient-Device Incompatibility (2682)
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	06/15/2020
Type of Reportable Event	Serious Injury
Event or Problem Description
Per symposium presentation during hernia week 2020 (b)(6)- "three cases of mesh infection after abdominal wall hernia requiring mesh removal" as reported that the patient underwent repair of an umbilical hernia and a bard/davol ventrio st mesh was implanted.It was reported that a mesh infection occurred approximately one and a half months after the operation.It was reported the patient was treated with conservative therapy (opening the wound and vac) but the infection did not resolve.Four months later, the patient underwent mesh removal and direct suturing was performed.It was also reported that the patient was doing well and discharged 72 days after the operation.
Additional Manufacturer Narrative
Based on the information obtained, no conclusion can be made.Postoperative infection is a known inherent risk of surgery.The instructions-for-use (ifu) supplied with the device identifies infection as a possible complication.In regards to infection, the warnings 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." without a lot number, review of the manufacturing records cannot be conducted.Note, the date of event is estimated based on the information available.Note, we were unable to locate an english translation of the attached article/abstract.If/when additional information be provided, a supplemental emdr will be submitted.

• 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: 12822172
• Report Number: 1213643-2021-20413
• Device Sequence Number: 5696418
• Product Code: FTL
• UDI-Device Identifier: 00801741031540
• UDI-Public: (01)00801741031540
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K101920
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Literature
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 11/01/2021

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: 5950050
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/29/2021
• Initial Report FDA Received Date: 11/16/2021
• 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: 50 YR
• Patient Sex: Male