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

Catalog Number	5955460
Medical Device Problem Code	Use of Device Problem (1670)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/21/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
As reported, the ventralight st w/ echo mesh was implanted beyond its labeled expiration date.There was no adverse outcome associated with the patient reported.The event is confirmed as a use related error, with no malfunction of the device.There was no reported patient injury, or any medical/surgical intervention due to the issue.A review of the manufacturing records was performed and found the lot was manufactured to specification.Note, the event date (01-dec-2025) is considered to be a best estimate based on the date of awareness.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, a ventralight st w/ echo with a labeled expiration date of 28-sep-2025 was implanted in a patient.There was no reported patient injury, change in course of treatment, or any medical/surgical intervention due to the issue; the mesh remains implanted.
Additional Manufacturer Narrative
As reported, the ventralight st w/ echo mesh was implanted beyond its labeled expiration date.There was no adverse outcome associated with the patient reported.The event is confirmed as a use related error, with no malfunction of the device.There was no reported patient injury, or any medical/surgical intervention due to the issue.A review of the manufacturing records was performed and found the lot was manufactured to specification.Addendum: this is an addendum to the initial mdr submitted to document additional information provided.Based on the information provided, it was confirmed that the expired ventralight st w/ echo mesh was not implanted on the patient as initially reported.It was placed in the body and then removed and replaced with another implant during the case.There was no adverse patient outcome as a result of this event.The customer alleges that two (2) ventralight st w/ echo mesh ordered (po # (b)(4)) and received on (b)(6) 2025 at providence st.Mary medical center.The customer alleged it was lot huhx0502 with an exp date of 28-sep-2025, past the labeled expiration date.Review of the po confirmed product shipped on the po and provided on (b)(6) 2025 was huks0201 that had an expiration date of 28-apr-2027.Review of distribution records confirmed that the reported lot (cat# 5955460, lot# huhx0502) was not shipped to providence st.Mary medical center by bd.Review identifies that 3rd party distributors medline and owens and minor did receive eight (8) units of lot huhx0502.There is no ability to track 3rd party orders.The most likely root cause of the alleged expired lot at the hospital is that it may have been purchased from a 3rd party distributor.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, a ventralight st w/ echo with a labeled expiration date of (b)(6) 2025 was implanted in a patient.There was no reported patient injury, change in course of treatment, or any medical/surgical intervention due to the issue; the mesh remains implanted.Addendum: the customer alleges that two (2) ventralight st w/ echo mesh ordered on (b)(6) 2025 were received at providence st.Mary medical center past the labeled expiration date of (b)(6) 2025.As reported, one of the mesh was inadvertently introduced into a patient during a robotic laparoscopic hernia repair procedure on (b)(6) 2025.The issue was identified during the procedure, and the mesh was removed and replaced with another device.No patient injury was reported.

• 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: 23877119
• Report Number: 1213643-2025-01250
• Device Sequence Number: 9605092
• Product Code: FTL
• UDI-Device Identifier: 00801741031724
• UDI-Public: (01)00801741031724(11)231006(17)250928(10)HUHX0502
• Combination Product (Y/N): N
• Initial Reporter State: CO
• Initial Reporter Country: US
• PMA/510(K) Number: K130968
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/20/2026

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
• Operator of Device: Health Professional
• Device Expiration Date: 09/28/2025
• Device Catalogue Number: 5955460
• Device Lot Number: HUHX0502
• 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: 12/01/2025
• Supplement Date Received by Manufacturer: 01/20/2026
• Initial Report FDA Received Date: 12/23/2025
• Supplement Report FDA Received Date: 02/04/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/06/2023
• 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 Sex: Unknown