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

Catalog Number	0115311
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Codes	Adhesion(s) (1695); Pain (1994); Scar Tissue (2060)
Date of Event	03/22/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Root cause is inconclusive; no conclusion can be made as to the extent to which the implant may have caused or contributed to the patient's postoperative course.Note, the manufacturing date (15-jun-2018) is considered to be a best estimate.This mdr represents the 3dmax mesh (device 2).An additional supplemental emdr was submitted to represent the 3dmax mesh (device 1).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
Per information provided: (b)(6) 2018- patient was diagnosed with bilaterally indirect inguinal hernia thereby underwent robotic-assisted laparoscopic repair with implant of 3dmax (device 1).Per op notes, ¿the hernia sac in the right inguinal region was identified and was dissected.Right inguinal hernia was quite large.Therefore, it was decided to perform left inguinal hernia repair in 6 weeks.A 3dmax (device 1) was placed in the periperitoneal region and sutured¿.(b)(6) 2018- patient was diagnosed with left indirect inguinal hernia thereby underwent robotic-assisted laparoscopic repair with implant of 3dmax (device 2).Per op notes, ¿the hernia sac in the left inguinal region was identified and dissected.A 3dmax (device 2) was placed in the left inguinal region and sutured¿.(b)(6) 2019- patient was diagnosed with pelvic and left groin pain, thereby underwent robotic assisted laparoscopic repair with explant of 3d max mesh (device 2).Per op notes, ¿scar tissue and adhesion were noticed and the left-sided mesh is accordioned at the medial aspect between the pubic bone and the bladder.3dmax (device 2) was excised.¿.

• Brand Name: 3DMAX
• 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: 23365697
• Report Number: 1213643-2025-01010
• Device Sequence Number: 12979292
• Product Code: FTL
• UDI-Device Identifier: 00801741030734
• UDI-Public: (01)00801741030734(17)230628(10)HUCT0926
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K081010
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: Other,Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 10/23/2025

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 Expiration Date: 06/28/2023
• Device Catalogue Number: 0115311
• Device Lot Number: HUCT0926
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/24/2025
• Initial Report FDA Received Date: 10/23/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/15/2018
• 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: 62 YR
• Patient Sex: Male
• Patient Weight: 88 KG