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

Catalog Number	0115310
Medical Device Problem Code	Patient-Device Incompatibility (2682)
Health Effect - Clinical Codes	Adhesion(s) (1695); Pain (1994)
Date of Event	05/06/2015
Type of Reportable Event	Serious Injury
Event or Problem Description
Per information provided: (b)(6) 2014 - patient was diagnosed with bilateral inguinal and right femoral hernia thereby underwent laparoscopic repair with the implant of two 3dmax mesh (right ¿ device #1 and left ¿ device #2).Per operative notes, ¿two 3dmax mesh (right ¿ device #1 and left ¿ device #2) was placed and sutured.¿ (b)(6) 2014 - patient was diagnosed with chronic postoperative pain, adhesion thereby underwent laparoscopic repair with the explant of right 3dmax mesh (device #1).Per operative notes, ¿no hernia sac was noted.Right side 3dmax mesh (device #1) was removed.¿ (b)(6) 2015 - patient was diagnosed with chronic postoperative pain, right genitofemoral neuralgia, fibromyalgia, adhesion thereby underwent robotic assisted repair with the explant of left side 3dmax mesh (device #2).Per operative notes, ¿left side 3dmax mesh (device #2) was removed.¿.
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.This emdr was submitted to represent the bard/davol 3dmax (device #2).An additional supplemental emdr was submitted to represent the bard/davol 3dmax (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.

• 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: 22370105
• Report Number: 1213643-2025-00541
• Device Sequence Number: 19936751
• Product Code: FTL
• UDI-Device Identifier: 00801741030727
• UDI-Public: (01)00801741030727
• Combination Product (Y/N): N
• Initial Reporter State: RI
• Initial Reporter Country: US
• PMA/510(K) Number: K081010
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2014
• Device Explanted Year: 2015
• Reporter Type: Manufacturer
• Report Source: Other,Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 06/17/2025

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: 0115310
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/11/2025
• Initial Report FDA Received Date: 07/01/2025
• 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 Age: 38 YR
• Patient Sex: Female