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

Catalog Number	5950040
Medical Device Problem Code	Patient-Device Incompatibility (2682)
Health Effect - Clinical Codes	Abscess (1690); Erythema (1840); Unspecified Infection (1930); Seroma (2069)
Date of Event	03/23/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
As reported per patient medical records: on (b)(6) 2023, the patient underwent robotic assisted, converted to open repair of a recurrent ventral incisional hernia with ventrio st mesh.The patient had pain and erythema in the ruq incision and underwent an exploratory procedure on (b)(6) 2023.During this procedure, the patient underwent drainage of an abscess and removal of infected mesh.Per the operative notes," her previous right upper quadrant incision was re-incised.This was carried down to the mesh which was in a pocket of fluid and fibrin exudate.This was cultured.The mesh was removed.".
Additional Manufacturer Narrative
Based on the information provided, no conclusions can be made.The information provided does not help to determine root cause for the patient¿s postoperative course.Review of manufacturing records confirms product was manufactured to specification.To date, this is the only reported complaint for this manufacturing lot of (b)(4) units released for distribution in july-2022.The adverse reactions section of the instructions-for-use (ifu) supplied with the device lists seroma and infection as possible complications.Regarding 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 mesh.An unresolved infection may require removal of the device.¿.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.H3 other text : not returned.

• 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: 16963500
• Report Number: 1213643-2023-00200
• Device Sequence Number: 5244176
• Product Code: FTL
• UDI-Device Identifier: 00801741031533
• UDI-Public: (01)00801741031533
• 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: 2023
• Device Explanted Year: 2023
• Reporter Type: Manufacturer
• Report Source: Other,Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 05/05/2023

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: 04/28/2024
• Device Catalogue Number: 5950040
• Device Lot Number: HUGS1704
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/27/2023
• Initial Report FDA Received Date: 05/19/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/22/2022
• 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: 73 KG