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

Catalog Number 5954680

Device Problem Material Perforation (2205)

Patient Problem Hernia (2240)

Event Date 12/03/2020

Event Type  Injury  

Manufacturer Narrative

About 3 months post-implant of the bard/davol ventralight st mesh, the patient reported a "hole in the mesh" and an ultrasound test indicated a possible hernia recurrence.However, based on the subsequent ct-scan performed and patient visit, the surgeon confirmed that no hernia recurrence was observed.As reported the mesh remains implants with no further intervention currently scheduled.Based on the information provided the possible cause of the patient¿s reported outcome of a ¿lump and swelling at the hernia repair site¿ is unclear and the condition of the mesh does not appear to be of concern to the surgeon.In addition, while it has been reported no hernia recurrence has occurred, hernia recurrence is a known inherent risk of hernia repair surgery.A review of the manufacturing records was performed and found that the lot was manufactured to specification.To date, this is the only reported complaint from this manufacturing lot of 207 units released for distribution in (b)(6) 2020.Note, the date of event is estimated based on the date of the initial ultrasound test performed.Should additional information be provided, a supplemental mdr will be submitted.

Event Description

As reported, the patient underwent unspecified surgery on (b)(6) 2020 for implant of a bard/davol ventralight st which was fixated using a bard/davol capsure straight fixation device and the mesh had a ¿hole¿ in it and more than likely ¿defected¿.As reported, recurrence hernia may have occurred from the hole in the mesh after implantation.As reported, based on a history of ¿lump and swelling at the hernia repair site¿, the patient underwent an ultrasound on (b)(6) 2020.The finding of this ultrasound indicated what ¿appears to be a defect in the hernia mesh with what appears to be fat extending through¿ with a final impression being stated as a "periumbilical hernia in the area of previous repair".However, a subsequent ct scan was performed which is reported to have confirmed there is no hernia recurrence in the area of the mesh.As reported, in addition, the surgeon has seen the patient and has confirmed there was no hernia recurrence.It is being reported, that no further intervention is currently being scheduled.

• Brand Name: VENTRALIGHT ST MESH
• 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: 11716188
• MDR Text Key: 247281279
• Report Number: 1213643-2021-20090
• Device Sequence Number: 1
• Product Code: FTL
• UDI-Device Identifier: 00801741031656
• UDI-Public: (01)00801741031656
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K101851
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 04/07/2021

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
• Device Operator: Health Professional
• Device Expiration Date: 06/28/2022
• Device Catalogue Number: 5954680
• Device Lot Number: HUES1059
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/30/2021
• Initial Date FDA Received: 04/23/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/14/2020
• 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: 61 YR