MAUDE Adverse Event Report: DAVOL INC., SUB. C.R. BARD, INC. VENTRALIGHT ST W/ ECHO; SURGICAL MESH

Catalog Number 5955460

Device Problems Use of Device Problem (1670); Improper or Incorrect Procedure or Method (2017)

Patient Problem Injury (2348)

Event Date 10/22/2019

Event Type  Injury  

Manufacturer Narrative

The warning section of the instructions-for-use states: "the echo ps positioning system (including the balloon, all connectors, and inflation tube) is to be removed from the patient and appropriately discarded as it is not part of the permanent implant." the instructions-for-use instructs the user to, "verify that the echo ps¿ positioning system including the balloon, all mesh connectors, and the inflation tube is fully intact, discard the echo ps¿ positioning system appropriately." the echo ps positioning system which is intended to be removed from the abdomen, was not removed from the patient during the procedure as prescribed in the instructions-for-use.This complaint is confirmed as a use related event with no malfunction of the device.Discarded.

Event Description

As reported on (b)(6) 2019 a ventralight st w/ echo ps device was used during a surgical procedure.As reported the surgeon completed and closed the patient and did not realize until the patient was in the recovery that he had forgotten to remove the positioning system from the patient.The patient was brought back to the operating room where the surgeon successfully removed the positioning system via a laparoscopic procedure.As reported, there was no injury to the patient and the patient has been discharged from the hospital.

• Brand Name: VENTRALIGHT ST W/ ECHO
• Type of Device: SURGICAL MESH
• Manufacturer (Section D): DAVOL INC., SUB. C.R. BARD, INC.; 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: laura sundberg ; 100 crossings blvd.; warwick, RI 02886 ; 4018258462
• MDR Report Key: 9289509
• MDR Text Key: 165418411
• Report Number: 1213643-2019-10731
• Device Sequence Number: 1
• Product Code: FTL
• UDI-Device Identifier: 00801741031724
• UDI-Public: (01)00801741031724
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K130968
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 11/07/2019

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: 12/28/2020
• Device Catalogue Number: 5955460
• Device Lot Number: HUCY1824
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 10/23/2019
• Initial Date FDA Received: 11/07/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/26/2019
• 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: 24 YR