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 Codes	Adhesion(s) (1695); Pain (1994); Hernia (2240)
Date of Event	07/03/2017
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.This mdr represents the bd 3dmax (device 1).An additional supplemental emdr was submitted to represent the bd 3dmax (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: on (b)(6) 2016: patient was diagnosed with bilateral inguinal hernia thereby underwent robotic assisted laparoscopic repair with implant of two 3dmax mesh (device 1 and 2).Per operative notes, ¿in the left side, indirect hernia was reduced and large 3dmax mesh (device 1) was placed and sutured.There was a large direct and indirect portion of hernia in right side that was reduced and another large 3dmax mesh (device 2) was placed and secured with sutures.¿ on (b)(6) 2017: patient was diagnosed with recurrent left inguinal hernia and chronic pain thereby underwent open repair with implant of polypropylene mesh with keyhole.Per operative notes, ¿an indirect left inguinal hernia sac was dissected and adhesions with fatty tissues were lysed.A large polypropylene mesh with keyhole was placed and secured with sutures.¿ (note: the mesh implanted in this procedure is unknown and there is not any product identifier provided for this product).On (b)(6) 2017: patient was diagnosed with recurrent right inguinal hernia thereby underwent open repair with implant of polypropylene mesh with keyhole.Per operative notes, ¿the indirect hernia sac with adhesions were removed and ilioinguinal nerve was excised.A polypropylene mesh with keyhole was placed over the recurrent defect and sutured circumferentially.¿ (note: the mesh implanted in this procedure is unknown and there is not any product identifier provided for this product).On (b)(6) 2018: patient was diagnosed with recurrent left inguinal hernia thereby underwent open repair with implant of synthetic mesh.Per operative notes, ¿in the left groin, scar tissue was divided and previously placed 3dmax mesh (device 1) and synthetic mesh was dissected and removed.The sizeable defect was reduced, and synthetic mesh was placed over the fascia 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: 23439624
• Report Number: 1213643-2025-01049
• Device Sequence Number: 8689660
• Product Code: FTL
• UDI-Device Identifier: 00801741030734
• UDI-Public: (01)00801741030734
• 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: 2016
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: Other,Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 10/27/2025

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: UNKNOWN
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/09/2025
• Initial Report FDA Received Date: 10/31/2025
• 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: 56 YR
• Patient Sex: Male