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

Catalog Number 5950007

Device Problem Patient-Device Incompatibility (2682)

Patient Problem Scar Tissue (2060)

Event Date 11/02/2016

Event Type  Injury  

Manufacturer Narrative

As reported, about one month post-implant of bard/davol ventralex st mesh, the patient was diagnosed with small area of fibrinous healing tissue and was treated with medication.As reported, the ae has resolved.The clinician has assessed the patient¿s postoperative course as being ¿possibly¿ related to the study device and definitely related to the index procedure, however, based on the information provided, no conclusion can be made.Not returned - remains implanted.

Event Description

Reported per clinical trial (b)(6): on (b)(6) 2016 - subject patient underwent a primary open laparotomy midline umbilical hernia (1.5cm x 2.5 cm) repair procedure during which a bard/davol ventralex st was placed in underlay fashion in an intra-peritoneally and was fixated using suture.The fascia and full skin closure was achieved using sutures and adhesive skin closure.The patient was discharged on (b)(6) 2016.On (b)(6) 2016 - fibrinous healing tissue and was prescribed with application of sulfasalazine topically for 1-2 weeks until fully healed.On (b)(6) 2017 - the ae is resolved.Per the study clinician, the reported adverse event has been assessed as moderate in severity, possibly related to the study device and definitely related to the index procedure.The outcome for this ae is reported as recovered/resolved.

• Brand Name: VENTRALEX ST
• Type of Device: 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: 14488541
• MDR Text Key: 292507526
• Report Number: 1213643-2022-00306
• Device Sequence Number: 1
• Product Code: FTL
• UDI-Device Identifier: 00801741031472
• UDI-Public: (01)00801741031472
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K101928
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Study,Health Professional,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 05/11/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/24/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 10/28/2017
• Device Catalogue Number: 5950007
• Device Lot Number: HUZI0813
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/28/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 69 YR
• Patient Sex: Female
• Patient Weight: 84 KG