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

Catalog Number	0116321
Medical Device Problem Code	Patient-Device Incompatibility (2682)
Health Effect - Clinical Code	Hernia (2240)
Date of Event	01/09/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
As reported, the patient had hernia recurrence post implant of 3dmax mid mesh and surgical intervention is required to repair the inguinal hernia but has not been scheduled yet.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 hernia recurrence.The adverse reaction section of the instructions-for-use, supplied with the device identifies hernia recurrence as 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 1,153 units.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, during an direct inguinal hernia repair a 3dmax mid mesh was implanted on 09-jan-2025.Post implant the patient was diagnosed with medium sized hernia recurrence during physical examination and surgical intervention is required to repair the hernia but has not been scheduled yet.

• Brand Name: 3DMAX MID
• 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: 24331704
• Report Number: 1213643-2026-00130
• Device Sequence Number: 21268526
• Product Code: FTL
• UDI-Device Identifier: 00801741200786
• UDI-Public: (01)00801741200786(11)250718(17)300628(10)HUKT1223
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K200818
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 01/27/2026

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: 0116321
• Device Lot Number: HUKT1223
• 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: 01/22/2026
• Initial Report FDA Received Date: 02/13/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/18/2025
• 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