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

Catalog Number	0115310
Medical Device Problem Code	Patient-Device Incompatibility (2682)
Health Effect - Clinical Codes	Nerve Damage (1979); Hernia (2240)
Date of Event	03/30/2015
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 3dmax mesh (device 2).Additional supplemental emdrs were submitted to represent the 3dmax mesh (device 1), perfix plug (device 3) and 3dmax mesh (device 4).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) 2009- patient was diagnosed with bilateral inguinal hernia thereby underwent laparoscopic repair with implant of 3dmax mesh (device 1 and 2).Per op notes, ¿on the right inguinal region, an indirect defect was identified and the hernia was reduced.A 3dmax mesh (device 1) was placed into that area and tacked.On the left inguinal region a 3dmax mesh (device 2) was placed into the abdominal cavity and tacked it in place.¿.On (b)(6) 2013- patient was diagnosed with recurrent right inguinal hernia, thereby underwent laparoscopic repair with implant of perfix plug (device 3).Per op notes, ¿the ilioinguinal nerve was dissected out and preserved.There was a direct hernia present in the right inguinal region which was dissected.The previously placed mesh was palpable and a small defect was noted between mesh and pubic tubercle.The patch from the perfix plug (device 3) was placed on the defect and sutured.Of note, the plug mesh was not used¿.On (b)(6) 2015- patient was diagnosed with recurrent left inguinal hernia, thereby underwent laparoscopic repair with implant of unknown mesh.Per op notes, ¿on the left inguinal region, the ilioinguinal nerve was dissected out and preserved.Recurrence hernia in the left inguinal region was identified.A mesh was sutured to the pubic tubercle.¿ (note: the mesh implanted during this procedure was unknown).On (b)(6) 2019- patient was diagnosed with recurrent bilateral inguinal hernia, thereby underwent robotic assisted laparoscopic repair with partial explant of 3dmax mesh (device 1), perfix plug (device 3) and implant of 3dmax mesh (device 4 and 5).Per op notes, ¿direct hernia identified in the right inguinal region and was dissected.Positive mesh (device 1) was removed.A large 3dmax mesh (device 4) was placed and sutured.On the left side, the hernia recurrence repaired by placing a 3dmax mesh (device 5)¿.

• 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: 24466491
• Report Number: 1213643-2026-00245
• Device Sequence Number: 15864104
• Product Code: FTL
• UDI-Device Identifier: 00801741030727
• UDI-Public: (01)00801741030727(17)140328(10)HUTB1220
• Combination Product (Y/N): N
• Initial Reporter State: RI
• Initial Reporter Country: US
• PMA/510(K) Number: K081010
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2009
• Reporter Type: Manufacturer
• Report Source: Other,Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 02/19/2026

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: 03/28/2014
• Device Catalogue Number: 0115310
• Device Lot Number: HUTB1220
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/04/2026
• Initial Report FDA Received Date: 02/27/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/15/2009
• 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: 61 YR
• Patient Sex: Male