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

Catalog Number	0115610
Medical Device Problem Code	Patient-Device Incompatibility (2682)
Health Effect - Clinical Codes	Pain (1994); Insufficient Information (4580)
Date of Event	05/30/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
No conclusions can be made.The patient's attorney alleges "past, present, and future damages, including but not limited to, mental and physical pain and suffering for severe and permanent personal injuries sustained by the patient"; however, no details have been provided.A review of the manufacturing records was performed and found that the lot was manufactured to specification.Note, the date of event is considered to be a best estimate as (30-may-2025) based on the date of awareness.Note, the manufacturing date (15-dec-2021) is considered to be a best estimate.This emdr represents the modified onflex (device #2).An additional emdr's were submitted to represents the ventralex st & 3dmax mid (device #1 & #3).Should additional information be provided, a supplemental emdr will be submitted.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
Attorney alleges that the patient underwent surgery for implant of bard/davol ventralex st on (b)(6) 2021, modified onflex on (b)(6) 2023 and 3dmax mid on (b)(6) 2024.As reported, the patient is making a claim for an adverse patient outcome against all the devices.Attorney alleges general allegations for "past, present, and future damages, including but not limited to, mental and physical pain and suffering for severe and permanent personal injuries sustained by the patient.¿ it is also alleged that the patient experienced emotional distress and the device was defective.

• Brand Name: MODIFIED ONFLEX
• 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: 22165815
• Report Number: 1213643-2025-00453
• Device Sequence Number: 13077281
• Product Code: FTL
• UDI-Device Identifier: 00801741095399
• UDI-Public: (01)00801741095399(17)241128(10)HUFZ0142
• Combination Product (Y/N): N
• Initial Reporter State: RI
• Initial Reporter Country: US
• PMA/510(K) Number: K142706
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Reporter Type: Manufacturer
• Report Source: Other,Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 05/31/2025

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: 11/28/2024
• Device Catalogue Number: 0115610
• Device Lot Number: HUFZ0142
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/30/2025
• Initial Report FDA Received Date: 06/09/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 12/15/2021
• 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: Disability
• Patient Sex: Male