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

Catalog Number	0117311
Medical Device Problem Code	Patient-Device Incompatibility (2682)
Health Effect - Clinical Codes	Nerve Damage (1979); Pain (1994); Scar Tissue (2060); Hernia (2240)
Date of Event	05/26/2015
Type of Reportable Event	Serious Injury
Event or Problem Description
Per information provided: (b)(6) 2010 - patient was diagnosed with left inguinal hernia thereby underwent open repair with implant of perfix plug (device 1).Per op notes, ¿a direct hernia defect was identified and excised.A perfix plug (device 1) was placed and secured with sutures.¿ (b)(6) 2012 - patient was diagnosed with recurrent left inguinal hernia, chronic left inguinodynia and meshoma thereby underwent laparoscopic repair with excision of perfix plug (device 1) and implant of 3dmax light (device 2).Per op notes, ¿the prior mesh plug (device 1) was noted, resected and removed.The direct hernia sac was identified and reduced.Ilioinguinal neurectomy was performed.Adhesions were lysed.A large 3dmax light (device 2) was placed and tacked.¿ (b)(6) 2015 - patient was diagnosed with chronic left inguinal pain and recurrent left inguinal hernia thereby underwent open repair with neurectomy and implant of bard flat mesh (device 3).Per op notes, ¿scar was excised.The genitofemoral and ilioinguinal nerve were identified at the area of inguinal canal.Significant scarring was noted.These nerves were dissected free and neurectomy was performed.The hernia defect was noted and reduced.A bard flat mesh (device 3) was placed and sutured¿.
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 light mesh (device 2).An additional supplemental emdr was submitted to represent the bard/davol 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.

• Brand Name: 3DMAX LIGHT
• 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: 23904385
• Report Number: 1213643-2025-01284
• Device Sequence Number: 18489170
• Product Code: FTL
• UDI-Device Identifier: 00801741031038
• UDI-Public: (01)00801741031038
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K091659
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2012
• Reporter Type: Manufacturer
• Report Source: Other,Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 12/23/2025

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: 0117311
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/05/2025
• Initial Report FDA Received Date: 12/29/2025
• 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; Disability
• Patient Age: 57 YR
• Patient Sex: Male