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 Codes	Adhesion(s) (1695); Hernia (2240)
Date of Event	10/02/2018
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-may-2015) is considered to be a best estimate.This emdr represents the 3dmax (device #2).An additional supplemental emdr was submitted to represent the 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.
Event or Problem Description
Per additional information provided: on (b)(6) 2015 ¿ patient was diagnosed with incarcerated right inguinal hernia thereby underwent laparoscopic repair with implant of two 3dmax mesh (device #1 and #2).Per operative notes, ¿hernia sac was dissected completely and hernia was repaired with two 3dmax mesh.The first 3dmax mesh (device #1) was inserted with cord slit and other 3dmax mesh (device #2) was placed over the first mesh (device #1) as buttress repair with sutures.¿ on (b)(6) 2018¿ patient was diagnosed with recurrent right inguinal hernia thereby underwent open repair with implant of perfix plug (device #3).Per operative notes, ¿the mass was identified at the pubic tubercle and noted to be closely adherent to the oval mesh (device #1 and #2).The mass was excised.Recurrent indirect inguinal hernia was identified and placed with perfix plug (device #3) and secured with sutures.¿.

• 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: 22540277
• Report Number: 1213643-2025-00651
• Device Sequence Number: 20590445
• Product Code: FTL
• UDI-Device Identifier: 00801741030758
• UDI-Public: (01)00801741030758(17)200528(10)HUZE0874
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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): 07/10/2025

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: 05/28/2020
• Device Catalogue Number: 0115320
• Device Lot Number: HUZE0874
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/02/2025
• Initial Report FDA Received Date: 07/18/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/15/2015
• 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: 53 YR
• Patient Sex: Male