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

Catalog Number	0115320
Medical Device Problem Codes	Defective Device (2588); Patient Device Interaction Problem (4001)
Health Effect - Clinical Codes	Abdominal Pain (1685); Hernia (2240); Obstruction/Occlusion (2422)
Date of Event	02/15/2016
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Based on the information provided, no conclusions can be made.Per medical records review, about 7 months post implant of 3dmax, patient was diagnosed with hernia recurrence, obstruction ad abdominal pain thereby underwent revision surgery.The instructions-for-use supplied with the device list hernia recurrence as a possible complication.This emdr represents the 3dmax mesh (device #1).An additional supplemental emdr was submitted to represent the 3dmax mesh (device #2) and an additional supplemental emdr was submitted to represent the perfix plug (device #3).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: on (b)(6) 2015, patient was diagnosed with bilateral symptomatic inguinal hernias thereby underwent laparoscopic total extraperitoneal repair with the implant of 3dmax meshes (device #1 & #2).Per operative notes, "on right side, there was scar tissue and the posterior peritoneum was stuck in the area.A direct inguinal hernia was noted, a 3dmax mesh (device #1) was positioned and tacked to the pubic tubercle and rolled out over the inguinal hernia and tucked into the sulcus.On left side, an indirect hernia was pulled down and swept off the cord and reduced.Another 3dmax mesh (device #2) was tacked down laterally and inferiorly into sulcus covering the defect." on (b)(6) 2015, patient visited hospital for pain and was diagnosed with left inguinal hernia.On (b)(6) 2015, patient was diagnosed with recurrent left indirect inguinal hernia thereby underwent open repair with the implant of perfix light plug (device #3).Per operative notes, "the hernia sac was identified, thickened and scarred.The previously placed mesh (device #2) was identified medially and inferiorly.A perfix light plug (device #3) was placed in preperitoneal space and sutured.The onlay mesh was placed on the inguinal floor." on (b)(6) 2016, patient visited hospital for groin hematoma.Attorney alleges that the patient had bowel obstruction, abdominal pain, hernia recurrence, pain and suffering.

• Brand Name: 3DMAX
• Common Device Name: SURGICAL MESH
• Manufacturer (Section D): DAVOL INC., SUB. C.R. BARD, INC.; 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 ; 4018258495
• MDR Report Key: 21535633
• Report Number: 1213643-2025-090125
• Device Sequence Number: 15466481
• Product Code: FTL
• UDI-Device Identifier: 00801741030758
• UDI-Public: (01)00801741030758
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Initial Reporter Country: US
• PMA/510(K) Number: K081010
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2015
• Reporter Type: Manufacturer
• Report Source: Other,Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 03/06/2025

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
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/11/2025
• Initial Report FDA Received Date: 03/06/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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: Other
• Patient Age: 43 YR
• Patient Sex: Male
• Patient Weight: 77 KG