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)
Date of Event	09/18/2020
Type of Reportable Event	Serious Injury
Event or Problem Description
Per information provided: (b)(6) 2015 - patient was diagnosed with right inguinal hernia and umbilical hernia thereby underwent laparoscopic and open repair with implant of 3dmax (device 1) and ventralex mesh (device 2).Per op notes, ¿the defect in the umbilicus was identified with bowel.The bowel was reduced.A ventralex mesh (device 2) was placed and secured with sutures.On the right inguinal region, the hernia defect was identified and reduced.A 3dmax (device 1) was placed and secured with sutures.¿ (b)(6) 2020 - patient was diagnosed with recurrent umbilical hernia with pain, recurrent left inguinal hernia and bilateral inguinal pain thereby underwent robotic assisted laparoscopic repair with excision of ventralex mesh (device 2) and implant of 3dmax light (device 3).Per op notes, ¿omental adhesions to prior mesh (device 2) were lysed.The extruding prior mesh (device 2) was excised entirely.The recurrent defect was repaired primarily with sutures.On the left inguinal region, an indirect hernia sac was noted and reduced separated from the cord structures.The ilioinguinal, genitofemoral and femoral cutaneous nerves were noted and portions were removed.A 3dmax light (device 3) was placed and sutured.On the right inguinal region, pain in the distribution of the ilioinguinal and genitofemoral nerves.The prior mesh (device 1) was in good position.No evidence of recurrence.The ilioinguinal, genitofemoral, femoral cutaneous nerves were excised and 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.Note, the manufacturing date (15-apr-2015) is considered to be a best estimate.This mdr represents the 3dmax (device 1).Additional supplemental emdr was submitted to represent the ventralex (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.

• 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: 24019072
• Report Number: 1213643-2026-00018
• Device Sequence Number: 10550103
• Product Code: FTL
• UDI-Device Identifier: 00801741030765
• UDI-Public: (01)00801741030765(17)200428(10)HUZD1314
• Combination Product (Y/N): N
• Initial Reporter State: MA
• 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): 01/08/2026

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: 04/28/2020
• Device Catalogue Number: 0115321
• Device Lot Number: HUZD1314
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/16/2025
• Initial Report FDA Received Date: 01/09/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/15/2015
• 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: 58 YR
• Patient Sex: Male