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

Catalog Number	0117321
Medical Device Problem Code	Patient-Device Incompatibility (2682)
Health Effect - Clinical Codes	Nerve Damage (1979); Scar Tissue (2060); Neuralgia (4413)
Date of Event	03/03/2017
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.Note, the manufacturing date (15-feb-2015) is considered to be a best estimate.This emdr was submitted to represent the bard/davol 3dmax light (device #4).An additional supplemental emdr represents the bard/davol kugel patch (device #1) and bard flat mesh (device #3).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: (b)(6) 2013 - patient was diagnosed with bilateral inguinal hernia thereby underwent open repair with implant of kugel hernia patch (device #1 & #2).Per operative notes, ¿the hernia sac was identified in right inguinal region and reduced.A kugel patch (device #1) was placed using sutures.The hernia sac was identified and reduced in left inguinal region.A kugel patch (device #2) was placed using sutures.(b)(6) 2014 - patient was diagnosed with recurrent right inguinal hernia thereby underwent open repair with implant of bard flat mesh (device #3).Per operative notes, ¿the prior kugel patch (device #1) appears to be displaced and migrated to hernia sac.The hernia contents were identified and reduced.A bard flat mesh (device #3) was placed and sutured.(b)(6) 2015 - patient was diagnosed with recurrent right inguinal hernia thereby underwent laparoscopic repair with partial excision of mesh (device #1 & #3) and implant of 3dmax light (device #4).Per operative notes, ¿the protruding mesh was cut and dissected off from abdominal wall.The scarring of nerve was identified.A small hernia defect was identified and repaired using 3dmax light (device #4) and tacked.(b)(6) 2017 - patient was diagnosed with right groin pain and neuralgia thereby underwent open repair with removal of mesh (device #1 & #3) and resection of nerves.Per operative notes, ¿moderate amount of scarring was excised.The prior mesh (device #1 & #3) with suture material was removed entirely.Three nerves were resected and sutured.

• 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: 22305336
• Report Number: 1213643-2025-00509
• Device Sequence Number: 20814400
• Product Code: FTL
• UDI-Device Identifier: 00801741031069
• UDI-Public: (01)00801741031069(17)200228(10)HUZB1152
• Combination Product (Y/N): N
• Initial Reporter State: RI
• Initial Reporter Country: US
• PMA/510(K) Number: K091659
• 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): 06/10/2025

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 Expiration Date: 02/28/2020
• Device Catalogue Number: 0117321
• Device Lot Number: HUZB1152
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/03/2025
• Initial Report FDA Received Date: 06/23/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/15/2015
• 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: 61 YR
• Patient Sex: Male