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

Catalog Number	0116312
Medical Device Problem Code	Patient-Device Incompatibility (2682)
Health Effect - Clinical Codes	Pain (1994); Burning Sensation (2146)
Date of Event	02/27/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
As reported, patient had left groin pain and burning sensation post implant of left 3dmax mid mesh.Upon exam the surgeon states, there is no problem with the mesh and or placement.It was reported that after reviewing the ct scan, the surgeon does not believe the pain was caused by the mesh and is more likely related to the incision/suturing of the flap.Review of manufacturing records shows product was manufactured to specification.To date, this is the only reported complaint for this manufacturing lot of (b)(6) 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, patient underwent an emergency bilateral inguinal hernia repair surgery with the implant of two 3dmax mid mesh (right and left) on (b)(6) 2025.About a week post implant, patient is having pain in the left groin and contact reports "the mesh feels like a piece of sandpaper inside of him and it is burning." patient presented for post-surgery follow up in (b)(6) 2025.The surgeon states no problem with mesh and or placement and suggests nerve damage or irritation of peritoneal flap.A ct scan was ordered and shows mild peri colonic peritoneal thickening.Per contact "the physician did not feel it was related to the hernia mesh after i had the ct scan" and stated "there's no belief by me or md that the unforeseen pain was related to the mesh - more related to the incision/suturing of the flap." patient was treated with medications (hydrocodone and gabapentin).

• 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: 21727313
• Report Number: 1213643-2025-00279
• Device Sequence Number: 18490444
• Product Code: FTL
• UDI-Device Identifier: 00801741200762
• UDI-Public: (01)00801741200762(17)290928(10)HUJW1787
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• 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,Consumer,User Facility,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 03/11/2025

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: 0116312
• Device Lot Number: HUJW1787
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/05/2025
• Initial Report FDA Received Date: 03/29/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/19/2024
• 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 Age: 53 YR
• Patient Sex: Male