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

Catalog Number	5954810
Medical Device Problem Code	Use of Device Problem (1670)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/28/2025
Type of Reportable Event	Malfunction
Event or Problem Description
As reported, a ventralight st mesh with a labeled expiration date of (b)(6) 2025 was implanted in the patient on (b)(6) 2025, which was beyond its labeled expiration date.There was no reported patient injury, change in course of treatment, or any medical/surgical intervention due to the issue.As reported, it was decided to leave the mesh implanted.
Additional Manufacturer Narrative
As reported, an expired ventralex st mesh was inadvertently implanted into the patient.The expiration date is included on the labeling of this product and is located on multiple levels of the packaging.This 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.Review of manufacturing records confirms product was manufactured to specification.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.
Additional Manufacturer Narrative
As reported, an expired ventralex st mesh was inadvertently implanted into the patient.The expiration date is included on the labeling of this product and is located on multiple levels of the packaging.This 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.Review of manufacturing records confirms product was manufactured to specification.Addendum: h11: this supplemental emdr is submitted to correct the manufacturer narrative.As reported, an expired ventralight st mesh was inadvertently implanted into the patient.The expiration date is included on the labeling of this product and is located on multiple levels of the packaging.This 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.Review of manufacturing records confirms product was manufactured to specification.Updated fields: b4, g3, g6, h2, h6, h11 corrected field: h10 (manufacturer narrative).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 mesh with a labeled expiration date of (b)(6) 2025 was implanted in the patient on (b)(6) 2025, which was beyond its labeled expiration date.There was no reported patient injury, change in course of treatment, or any medical/surgical intervention due to the issue.As reported, it was decided to leave the mesh implanted.

• Brand Name: VENTRALIGHT ST MESH
• 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: 22749091
• Report Number: 1213643-2025-00739
• Device Sequence Number: 9547316
• Product Code: FTL
• UDI-Device Identifier: 00801741031687
• UDI-Public: (01)00801741031687(11)230707(17)250628(10)HUHU0258
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Initial Reporter Country: US
• PMA/510(K) Number: K101851
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 08/18/2025

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: 06/28/2025
• Device Catalogue Number: 5954810
• Device Lot Number: HUHU0258
• 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: 07/28/2025
• Supplement Date Received by Manufacturer: 08/14/2025
• Initial Report FDA Received Date: 08/08/2025
• Supplement Report FDA Received Date: 08/19/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/07/2023
• 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