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 Codes	Fever (1858); Unspecified Infection (1930); Pain (1994)
Date of Event	11/21/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
As reported, on (b)(6) 2025, the patient underwent a tapp procedure to treat a right inguinal hernia using a 3dmax mid mesh.At three weeks post-operation, the patient developed pain at the surgical site and fever, requiring readmission.Mesh infection was noted and the mesh was explanted on (b)(6) 2025.
Additional Manufacturer Narrative
As alleged, following implantation of the 3dmax mid mesh, the patient experienced pain and fever and was subsequently diagnosed with a mesh infection, requiring explantation of the mesh.Postoperative infection is a clinically understood potential complication of surgery/use of the device.The instructions-for-use provided with the device, identifies infection as a possible complication and 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." the degree to which the implant used to treat the patient, may have caused or contributed to the patient¿s postoperative course is unknown.A review of the manufacturing records confirmed that the lot was manufactured according to specifications.To date, this is the only reported complaint for this manufacturing lot of (b)(4) 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.

• 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: 23820954
• Report Number: 1213643-2025-01231
• Device Sequence Number: 9295324
• Product Code: FTL
• UDI-Device Identifier: 00801741200786
• UDI-Public: (01)00801741200786(11)250424(17)300228(10)HUKQ1169
• 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
• Device Explanted 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): 12/01/2025

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: 0116321
• Device Lot Number: HUKQ1169
• 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: 11/27/2025
• Initial Report FDA Received Date: 12/16/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/24/2025
• 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