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

Catalog Number 5954460

Device Problem Expiration Date Error (2528)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 09/26/2022

Event Type  malfunction  

Manufacturer Narrative

As reported, an expired ventralight st mesh was inadvertently implanted into the patient.The expiration date is located on multiple layers of the packaging.This event is confirmed as a use related error with no malfunction of the device.No patient injury was reported.Not returned - remains implanted.

Event Description

As reported, during a robotic umbilical hernia repair procedure on (b)(6) 2022, the surgeon implanted a bard/davol ventralight st mesh which was expired on (b)(6) 2022 in a patient.It was reported that the mesh has been left implanted and the patient has not received any additional medical/surgical treatment.There was no reported patient injury.

• 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: 15625159
• MDR Text Key: 302594805
• Report Number: 1213643-2022-00653
• Device Sequence Number: 1
• Product Code: FTL
• UDI-Device Identifier: 00801741031625
• UDI-Public: (01)00801741031625
• 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: Other,Health Professional,User Facility
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 10/04/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/28/2022
• Device Catalogue Number: 5954460
• Device Lot Number: HUEW0841
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 09/27/2022
• Initial Date FDA Received: 10/18/2022
• 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): Other