MAUDE Adverse Event Report: DAVOL INC., SUB. C.R. BARD, INC. -1213643 VENTRALIGHT ST W/ ECHO 2; SURGICAL MESH

Catalog Number	5990011
Medical Device Problem Code	Patient-Device Incompatibility (2682)
Health Effect - Clinical Code	Hypersensitivity/Allergic reaction (1907)
Date of Event	04/10/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
As reported, the patient underwent laparoscopic ventral hernia repair on (b)(6) 2024 with the ventralight st w/ echo 2.The patient has had discomfort in the area of the mesh, and "seems to be having an allergic reaction." the surgeon and allergist would like to perform a reactivity test; a sample mesh has been provided for reactivity testing.
Additional Manufacturer Narrative
As reported, the patient had a possible allergic reaction post implant of a ventralight st mesh using echo 2 ps.A mesh sample has been provided to the doctor to perform reactivity testing.At this time, no conclusion can be made.If/when reactivity test results are provided, a supplemental mdr will be submitted.The adverse reactions section of the instructions-for-use supplied with the device lists allergic reaction as a possible complication.Review of manufacturing records confirms the product was manufactured to specification.To date, this is the only reported complaint for this manufacturing lot of (b)(4) units.Note, the date of event is considered to be best estimate as 10-apr-2025 based on the awareness date and the date of implant is considered to be a best estimate as on (b)(6) 2024 based on the information received, as a specific implant date was not provided.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, the patient had a possible allergic reaction post implant of a ventralight st mesh using echo 2 ps.A mesh sample has been provided to the doctor to perform reactivity testing.At this time, no conclusion can be made.If/when reactivity test results are provided, a supplemental mdr will be submitted.The adverse reactions section of the instructions-for-use supplied with the device lists allergic reaction as a possible complication.Review of manufacturing records confirms the product was manufactured to specification.To date, this is the only reported complaint for this manufacturing lot of (b)(4) units.Note, the date of event is considered to be best estimate as 10-apr-2025 based on the awareness date and the date of implant is considered to be a best estimate as (b)(6) 2024 based on the information received, as a specific implant date was not provided.Addendum: h11: this supplemental mdr is submitted to document the reactivity test result.Reactivity testing has been performed and as reported the results were negative for an allergic response to the mesh sample.It is unknown at this time, what is causing the patient's condition.However, based on testing performed the postoperative conditions experienced by the patient do not appear to be caused by the ventralight st mesh w/ echo 2 ps used to treat the patient.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 laparoscopic ventral hernia repair in (b)(6) 2024 with the ventralight st w/ echo 2.The patient has had discomfort in the area of the mesh, and "seems to be having an allergic reaction." the surgeon and allergist would like to perform a reactivity test; a sample mesh has been provided for reactivity testing.Addendum: reactivity test results came back negative on the patient; there was no reaction to the mesh.

• Brand Name: VENTRALIGHT ST W/ ECHO 2
• 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: 21952122
• Report Number: 1213643-2025-00354
• Device Sequence Number: 15633421
• Product Code: FTL
• UDI-Device Identifier: 00801741130977
• UDI-Public: (01)00801741130977(11)230517(17)240428(10)HUHS0515
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Initial Reporter Country: US
• PMA/510(K) Number: K170294
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Reporter Type: Manufacturer
• Report Source: Other,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 05/08/2025

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: 04/28/2024
• Device Catalogue Number: 5990011
• Device Lot Number: HUHS0515
• 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: 04/10/2025
• Supplement Date Received by Manufacturer: 05/08/2025
• Initial Report FDA Received Date: 05/02/2025
• Supplement Report FDA Received Date: 05/13/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/17/2023
• 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: Required Intervention
• Patient Sex: Unknown