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

Catalog Number	0115321
Medical Device Problem Code	Patient-Device Incompatibility (2682)
Health Effect - Clinical Codes	Nerve Damage (1979); Pain (1994); Hernia (2240)
Date of Event	09/11/2019
Type of Reportable Event	Serious Injury
Event or Problem Description
Per information provided: on (b)(6) 2009 - patient underwent repair with implant of 3dmax mesh (device 1).(note: there is no operative notes provided for this procedure in plaintiff profile form and medical records).On (b)(6) 2018 - patient was diagnosed with right inguinal hernia thereby underwent robotic assisted repair with implant of 3dmax mesh (device 2).Per op notes, ¿a vertical incision was made.Adhesions were noted in the intraabdominal space, and it was dissected and lysed.A hernia containing cecum and appendix was identified in the right inguinal canal and this was incarcerated in the hernia defect.The hernia sac was taken down.The bladder was densely adhered to the anterior abdominal wall and taken down.The hernia sac was taken out of the right inguinal and completely reduced.A piece of 3dmax mesh (device 2) was placed in the right inguinal canal and covered both the direct, indirect and femoral hernia defect spaces, and secured with sutures.¿ on (b)(6) 2019 - patient was diagnosed with recurrent right inguinal hernia thereby underwent open repair with implant of bard mesh pre-shaped with keyhole (device 3).Per op notes, ¿an oblique incision was made between the right pubic tubercle and right asis.The ilioinguinal nerve was identified, skeletonized and excised.The hernia sac was identified and reduced.A piece of bard mesh pre-shaped with keyhole (device 3) was placed into the right inguinal canal and secured into the pubic tubercle 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).An additional supplemental emdr was submitted to represent the 3dmax mesh (device 1).Note, the manufacturing date (15-aug-2018) is considered to be a best estimate.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: 24615616
• Report Number: 1213643-2026-00336
• Device Sequence Number: 18535609
• Product Code: FTL
• UDI-Device Identifier: 00801741030765
• UDI-Public: (01)00801741030765(17)230828(10)HUCV2035
• Combination Product (Y/N): N
• Initial Reporter State: AL
• Initial Reporter Country: US
• PMA/510(K) Number: K081010
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: Other,Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 03/09/2026

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: 08/28/2023
• Device Catalogue Number: 0115321
• Device Lot Number: HUCV2035
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/24/2026
• Initial Report FDA Received Date: 03/17/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/15/2018
• 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: 44 YR
• Patient Sex: Male
• Patient Weight: 108 KG