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 Code	Abdominal Pain (1685)
Date of Event	11/19/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
As reported, the patient had right sided abdominal pain post-implant of 3dmax mesh and approximately one year later underwent an additional surgery and was implanted with a non-bd mesh.Contact reports pain on the left side, however it is less severe.Contact information was not provided as such requests for additional information cannot be made.Based on the information provided, no conclusions can be made as to the degree to which the implant may have caused or contributed to the patient's postoperative pain.Pain is listed in the adverse reactions section of the instructions-for-use supplied with the device as possible complication.A review of manufacturing records was conducted and shows the product was manufactured to specification.To date, this is the only reported complaint for this manufacturing lot of (b)(4) units.This emdr represents the 3dmax right mesh (device 2).An additional emdr was submitted to represent the 3dmax left mesh (device 1).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 by patient via ansm report (n° r2601107): "i had my first surgery on (b)(6) 2023, for a left and right inguinal hernia.A becton dickinson 3dmax mesh was placed on each side of my abdomen.Following pain on the right side, i underwent a second operation on (b)(6) 2024.A cousin bioserv biomesh plate was placed, but the pain is still present on the right side.There is also pain on the left side, but it is less severe." on (b)(6) 2023, the patient underwent bilateral inguinal hernia repair by laparoscopic approach (mhj) and implanted with 3dmax mesh left and right.On (b)(6) 2024, a lichtenstein biomesh a2 plate was implanted.Current patient status: nr.Actions taken at the healthcare facility to treat the patient: nr.This report represents device #2 (3dmax-right).

• 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: 24306397
• Report Number: 1213643-2026-00098
• Device Sequence Number: 20162282
• Product Code: FTL
• UDI-Device Identifier: 00801741030765
• UDI-Public: (01)00801741030765(17)280228(10)HUHQ0761
• 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: 2023
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 01/22/2026

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 Catalogue Number: 0115321
• Device Lot Number: HUHQ0761
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/20/2026
• Initial Report FDA Received Date: 02/10/2026
• 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: Male
• Patient Weight: 90 KG