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	Abscess (1690); Unspecified Infection (1930); Pain (1994)
Date of Event	12/15/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
As reported, two months post 3dmax mid implant imagining revealed an abscess-like lesion pain and developed abscess and elevated white blood cell counts suggest infection.No conclusions can be made regarding the degree to which the 3dmax mid mesh implant used to treat the patient, may be causing, or contributing to the patient's postoperative course.A review of the manufacturing records was performed and found the lot was manufactured according to specification.To date, this is the only reported complaint for this manufacturing lot of (b)(4).Pain and infection are listed as possible complications in the adverse reactions section of the instructions-for-use, provided with the device.Regarding infection the warnings 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 reported, on (b)(6) 2025, patient underwent tapp repair for a left inguinal hernia and was implanted with a 3dmax mid mesh.It was reported that the patient slowly developed postoperative pain, tightness and redness at the surgical site.About two months later imaging revealed an abscess-like lesion, and elevated white blood cell counts suggest infection.Possibility of reoperation and mesh removal.Suspected mesh infection.Patient had administration of antibiotics.

• 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: 23959161
• Report Number: 1213643-2025-01309
• Device Sequence Number: 5611807
• Product Code: FTL
• UDI-Device Identifier: 00801741200755
• UDI-Public: (01)00801741200755(17)300228(10)HUKQ1186
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 12/17/2025

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 Catalogue Number: 0116311
• Device Lot Number: HUKQ1186
• 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: 12/16/2025
• Initial Report FDA Received Date: 01/05/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/20/2025
• 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: Required Intervention
• Patient Sex: Unknown