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

Catalog Number	0116311
Medical Device Problem Code	Patient-Device Incompatibility (2682)
Health Effect - Clinical Codes	Discomfort (2330); Wound Infection (2447)
Date of Event	05/01/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
As alleged, the patient experienced infection and discomfort at the surgical site several months post implant of 3dmax mid left mesh.The mesh remains implanted at this time and the wound is being managed with wound irrigation.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 delayed postoperative infection.No lot number has been provided; therefore, a review of the manufacturing records is not possible.The adverse reactions section of the instructions-for-use supplied with the device lists infection as a possible complication.Regarding infection the warning section states, "if an infection develops, treat the infection aggressively.Consideration should be given regarding the need to remove the mesh.An unresolved infection may require removal of the mesh".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 alleged, the patient underwent a procedure in may 2025 and was implanted with a 3dmax mid left mesh.As reported several months post implant the patient experienced a delayed infection.The wound is being managed with wound irrigation and the patient is currently having "discomfort at the surgical site, that seems to be infected" and is planning to investigate and consider treatment options.

• 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: 24388803
• Report Number: 1213643-2026-00187
• Device Sequence Number: 21462308
• Product Code: FTL
• UDI-Device Identifier: 00801741200755
• UDI-Public: (01)00801741200755
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K200818
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• 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): 02/03/2026

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: 0116311
• 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: 01/31/2026
• Initial Report FDA Received Date: 02/19/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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