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

Catalog Number	0115311
Medical Device Problem Code	Patient-Device Incompatibility (2682)
Health Effect - Clinical Code	Hernia (2240)
Date of Event	07/23/2013
Type of Reportable Event	Serious Injury
Event or Problem Description
Per information provided: (b)(6) 2007 - patient was diagnosed with bilateral symptomatic inguinal hernia thereby underwent laparoscopic repair with implant of 3dmax mesh (device 1 ¿ right and device 2 ¿ left).Per operative notes, ¿an incision was made just below the umbilicus.On the right side right inguinal hernia sac was dissected out.A 3dmax mesh (device 1- right) was placed and secure it with sutures.On the left inguinal side, hernia sac was dissected out.A 3dmax mesh (device 2 ¿ left) was placed on the left inguinal hernia site and secure it with sutures.¿ (b)(6) 2013 - patient was diagnosed with recurrent right inguinal hernia thereby underwent open repair with implant of perfix plug (device 3).Per operative notes, ¿an incision was made in the right groin.The spermatic cord was then dissected out.The hernia sac was dissected out.A perfix plug (device 3) was placed into the right inguinal site and secure it with sutures.¿ (b)(6) 2013 - patient was diagnosed with left inguinal hernia thereby underwent open repair with implant of synthetic mesh.Per operative notes, ¿an incision was made in the midportion of the external oblique.The left inguinal hernia sac was dissected out.A synthetic mesh was then placed into the left inguinal floor and secure it with sutures.¿ (b)(6) 2019 - patient was diagnosed with recurrent right inguinal hernia, pain, thereby underwent robotic repair with explant of 3dmax mesh (device 1- right) and perfix plug (device 3) and implant of synthetic mesh.Per operative notes, ¿an incision was made into the right inguinal side.The hernia sac was dissected out.Previously placed 3dmax mesh (device 1- right) and perfix plug (device 3) were removed.A synthetic mesh was placed on the right side.On the left side there was no hernia sac was not present.The defect was closed with sutures.¿.
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 2).Additional supplemental emdr's were submitted to represent the 3dmax mesh (device 1) and 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.

• 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: 23942761
• Report Number: 1213643-2025-01300
• Device Sequence Number: 7830189
• Product Code: FTL
• UDI-Device Identifier: 00801741030734
• UDI-Public: (01)00801741030734(10)43IQD017
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K081010
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2007
• Reporter Type: Manufacturer
• Report Source: Other,Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 12/31/2025

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: 0115311
• Device Lot Number: 43IQD017
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/08/2025
• Initial Report FDA Received Date: 01/02/2026
• 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: 52 YR
• Patient Sex: Male