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

Catalog Number	5955810
Medical Device Problem Code	Improper or Incorrect Procedure or Method (2017)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	06/20/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
As reported, the echo ps¿ component of the ventralight st echo ps¿ was not removed from the patient's body following mesh implant and was identified during a subsequent surgical procedure conducted approximately 1.5 years later.The echo ps¿ was removed at that time with no patient injury.Based on the information provided the reported event is determined to be use related with no malfunction of the device.The instructions-for-use, supplied with the device states, ventralight¿ st mesh is the only permanent implant component of the device.The inflation adapter and syringe are to be kept external to the patient and discarded after use.The echo ps¿ positioning system (including the balloon, all connectors, and inflation tube) must be removed from the patient and appropriately discarded.It is not part of the permanent implant.And "visualization must be maintained throughout the course of the entire procedure.Additionally, laparoscopic removal of the echo ps¿ positioning system must be performed under sufficient visualization of the entire device and surrounding anatomy to ensure proper removal.¿ a review of the manufacturing records was performed and found the lot was manufactured to specification.To date, this is the only reported complaint for this manufacturing lot of 205 units.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.
Event or Problem Description
As reported, the patient underwent a laparoscopic ventral hernia repair on (b)(6) 2023, during which a ventralight st with echo ps was used for the repair.On (b)(6) -2025, during a subsequent robotic incisional hernia repair procedure, it was discovered that the previously implanted echo ps remained inside the patient's body.The echo ps was removed during the procedure and it was reported that the mesh was intact with no faults or defects.There was no patient injury.

• Brand Name: VENTRALIGHT ST W/ ECHO
• 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: 22716206
• Report Number: 1213643-2025-00719
• Device Sequence Number: 9627776
• Product Code: FTL
• UDI-Device Identifier: 00801741031786
• UDI-Public: (01)00801741031786(17)240628(10)HUGU2184
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K122436
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Reporter Type: Manufacturer
• Report Source: Other,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 07/23/2025

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: 06/28/2024
• Device Catalogue Number: 5955810
• Device Lot Number: HUGU2184
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/14/2025
• Initial Report FDA Received Date: 08/05/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/27/2022
• 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: Other
• Patient Age: 72 YR
• Patient Sex: Male