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

Catalog Number	0115320
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Codes	Hematoma (1884); Pain (1994)
Date of Event	11/12/2017
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-jun-2017) is considered to be a best estimate.This mdr represents the 3dmax mesh (device 2).An additional supplemental emdr was submitted to represent the perfix plug (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 information provided: (b)(6) 2013- patient was diagnosed with direct right inguinal hernia and pain, thereby underwent open repair with implant of perfix plug (device 1).Per op notes, ¿a small direct inguinal hernia was identified in the right inguinal region.A perfix plug (device 1) was placed into the direct space and sutured¿.(b)(6) 2017 - patient was diagnosed with right inguinal hernia and right groin pain, thereby underwent robotic assisted laparoscopic repair with implant of 3dmax mesh (device 2).Per op notes, ¿a piece of mesh that was wadded into a bunch almost like a plug so the inferior aspect had a persistent hernia.A 3dmax mesh (device 2) was placed over the hernia defect, across the pubic symphysis and was sutured¿.(b)(6) 2017- patient was diagnosed with pelvic hematoma and prostate cancer, thereby underwent open repair with explant of perfix plug (device 1) and 3dmax mesh (device 2).Per op notes, ¿abdomen shows displacement of mesh (device 1- perfix plug, device 2- 3dmax mesh) which was sharply removed¿.

• 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: 24207018
• Report Number: 1213643-2026-00047
• Device Sequence Number: 9855586
• Product Code: FTL
• UDI-Device Identifier: 00801741030758
• UDI-Public: (01)00801741030758(17)220628(10)HUBT1648
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K081010
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: Other,Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 01/21/2026

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: 06/28/2022
• Device Catalogue Number: 0115320
• Device Lot Number: HUBT1648
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/08/2026
• Initial Report FDA Received Date: 01/29/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/15/2017
• 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: 55 YR
• Patient Sex: Male
• Patient Weight: 77 KG