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 Code	Abdominal Pain (1685)
Date of Event	05/03/2017
Type of Reportable Event	Serious Injury
Event or Problem Description
Per information provided: (b)(6) 2015- patient was diagnosed with bilateral inguinal hernia thereby underwent laparoscopic repair with implant of 3dmax light meshes (device 1 and 2).Per op notes, ¿indirect hernia sac was identified in the right and left inguinal region and were dissected.A 3dmax light meshes (device 1 and 2) were placed in the right and left position with adequate medial overlap covering from bilateral myopectineal orifices and tacked¿.(b)(6) 2017- patient was diagnosed with recurrent right inguinal hernia, right groin pain, left inguinal pain, abdominal pain, thereby underwent laparoscopic repair with explant of 3dmax light mesh (device 1) and implant of synthetic mesh.Per op notes, ¿a small right indirect inguinal hernia was identified underneath the mesh (device 1).There was no recurrent hernia or adhesions on the left side.The mesh in the right side (3dmax light mesh-device 1) was dissected.A synthetic mesh was placed into right preperitoneal space and tacked¿.(b)(6) 2018- patient was diagnosed with left inguinal groin pain, thereby underwent robotic assisted laparoscopic repair.Per op notes, ¿minimal adhesions were noted on the right groin region and was lysed.The 3dmax light mesh (device 2) was encountered and the tack was removed and no injuries in the 3dmax light mesh (device 2).¿.
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 3dmax light mesh (device 1).Note, the manufacturing date (15-oct-2014) 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 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: 24797035
• Report Number: 1213643-2026-00438
• Device Sequence Number: 15837246
• Product Code: FTL
• UDI-Device Identifier: 00801741031038
• UDI-Public: (01)00801741031038(17)191028(10)HUYJ1239
• Combination Product (Y/N): N
• Initial Reporter State: MO
• 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): 03/24/2026

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: 10/28/2019
• Device Catalogue Number: 0117311
• Device Lot Number: HUYJ1239
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/17/2026
• Initial Report FDA Received Date: 04/07/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/15/2014
• 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: 48 YR
• Patient Sex: Male
• Patient Weight: 68 KG