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

Catalog Number	0115320
Medical Device Problem Code	Patient-Device Incompatibility (2682)
Health Effect - Clinical Code	Hernia (2240)
Date of Event	06/14/2010
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.This mdr represents the 3dmax mesh (device #1).An additional supplemental emdr was submitted to represent the perfix plug (device #2).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) 2004 ¿ patient was diagnosed with right direct inguinal hernia thereby underwent laparoscopic repair with implant of 3dmax mesh (device #1).Per operative notes, ¿in the direct space, hernia was apparent and reduced.A 3dmax mesh (device #1) was placed and sutured.¿ (b)(6) 2005 ¿ patient underwent right inguinal hernia repair.(note: there is no operative notes provided for this procedure in medical records) (b)(6) 2008 ¿ patient underwent left inguinal hernia repair.(note: there is no operative notes provided for this procedure in medical records) (b)(6) 2009 ¿ patient was diagnosed with left inguinal hernia thereby underwent open repair with implant of perfix plug (device #2).Per operative notes, ¿both direct and indirect inguinal hernia was identified.A perfix plug (device #2) was placed and secured with sutures.¿ (b)(6) 2010 ¿ patient was diagnosed with recurrent direct left inguinal hernia and pain thereby underwent open repair with implant of synthetic mesh.Per operative notes, ¿recurrence in direct space was noted and mesh (device #2) appeared to have come away superior.A synthetic mesh was placed in the preperitoneal space and sutured.¿.

• 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: 22685778
• Report Number: 1213643-2025-00711
• Device Sequence Number: 8864434
• Product Code: FTL
• UDI-Device Identifier: 00801741030758
• UDI-Public: (01)00801741030758(10)43JND408
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K081010
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2004
• Reporter Type: Manufacturer
• Report Source: Other,Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 07/25/2025

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: 0115320
• Device Lot Number: 43JND408
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/14/2025
• Initial Report FDA Received Date: 08/01/2025
• 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: 29 YR
• Patient Sex: Male
• Patient Weight: 73 KG