MAUDE Adverse Event Report: DAVOL INC., SUB. C.R. BARD, INC. -1213643 3DMAX; SURGICAL MESH

Catalog Number	0115321
Medical Device Problem Code	Patient-Device Incompatibility (2682)
Health Effect - Clinical Codes	Abdominal Pain (1685); Seroma (2069); Ambulation or Postural Difficulties (2544)
Date of Event	06/12/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
As reported per ansm report (r2604195): as report, the patient underwent implant of two 3dmax mesh (left and right) devices on (b)(6) 2021, during the repair of bilateral inguinal hernias.Date of event - 12-jun-2021 description of the incident: pain in the lower abdomen and thighs.Comments: mri (b)(6) 2021: small fluid pocket around the prostheses.Patient's current condition : unbearable pain 24 hours a day.Difficulty walking, sleeping.Actions taken in the hospital to manage the patient: nr this report represents 3dmax mesh right.
Additional Manufacturer Narrative
As alleged, the patient experienced pain, difficulty in walking/sleeping and a small pocket of fluid was noted on the mri scan post implant of 3dmax mesh.Based on the information available to date, no conclusions can be made as to the degree to which the implant may have caused or contributed to the patient's postoperative complications.The adverse reaction section of the instructions-for-use (ifu), supplied with the device identifies pain and seroma as possible complications.Review of manufacturing records confirms the product was manufactured to specification.To date, this is the only complaint for the reported lot of 1,274 units released for distribution.This emdr represents the 3dmax mesh right.An additional emdr was submitted to represent the 3dmax mesh left.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.

• Brand Name: 3DMAX
• 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: 24496590
• Report Number: 1213643-2026-00272
• Device Sequence Number: 4966850
• Product Code: FTL
• UDI-Device Identifier: 00801741030765
• UDI-Public: (01)00801741030765(17)250828(10)HUEV1639
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K081010
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 02/12/2026

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: 08/28/2025
• Device Catalogue Number: 0115321
• Device Lot Number: HUEV1639
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/11/2026
• Initial Report FDA Received Date: 03/03/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/25/2020
• 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: Male
• Patient Weight: 85 KG