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

Catalog Number	UNKAA002
Medical Device Problem Code	Patient-Device Incompatibility (2682)
Health Effect - Clinical Codes	Abdominal Pain (1685); Inflammation (1932); Fibrosis (3167); Back pain (4895)
Date of Event	09/15/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
As reported, since the implantation of 3dmax light mesh the patient has been experiencing inflammatory symptoms, fibrosis and chronic abdominal/back pain.Based on the information available to date, no conclusions can be made as to the degree to which the implant may have caused or contributed to the patient's postoperative complications.The adverse reaction section of the instructions-for-use, supplied with the device identifies pain and inflammation as possible complications.Review of manufacturing records confirms the product was manufactured to specification.Note, the date of event (15-sep-2022) is considered to be the 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.
Event or Problem Description
As reported, in (b)(6) 2022 the patient underwent a hernia repair procedure and was implanted with a 3dmax light mesh.It was reported that since the procedure the patient has been experiencing inflammatory symptoms, fibrosis and chronic abdominal/back pain.
Event or Problem Description
As reported, in (b)(6) 2022 the patient underwent a hernia repair procedure and was implanted with a 3dmax light mesh.It was reported that since the procedure the patient has been experiencing inflammatory symptoms, fibrosis and chronic abdominal/back pain.
Additional Manufacturer Narrative
As reported, since the implantation of 3dmax light mesh the patient has been experiencing inflammatory symptoms, fibrosis and chronic abdominal/back pain.Based on the information available to date, no conclusions can be made as to the degree to which the implant may have caused or contributed to the patient's postoperative complications.The adverse reaction section of the instructions-for-use, supplied with the device identifies pain and inflammation as possible complications.Review of manufacturing records confirms the product was manufactured to specification.Note, the date of event (15-sep-2022) is considered to be the best estimate.Addendum: this is an addendum to the initial mdr submitted to correct the product identifiers and to report that the provided medical device lot # does not correspond to the device implanted in the patient.Upon further review, it was noted that the patient was implanted with the 3dmax light in 2022; however, the medical device lot # provided was manufactured in 2024.It was identified that the provided medical device lot # does not correspond to the device implanted in the patient on 2022.Updated fields: b4, g3, g6, h2, h6, h10, h11.Corrected fields: d4 (medical device catalog/lot/expiration date and udi).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.
Additional Manufacturer Narrative
As reported, since the implantation of 3dmax light mesh the patient has been experiencing inflammatory symptoms, fibrosis and chronic abdominal/back pain.Based on the information available to date, no conclusions can be made as to the degree to which the implant may have caused or contributed to the patient's postoperative complications.The adverse reaction section of the instructions-for-use, supplied with the device identifies pain and inflammation as possible complications.Review of manufacturing records confirms the product was manufactured to specification.Note, the date of event (15-sep-2022) is considered to be the best estimate.Addendum 1: this is an addendum to the initial mdr submitted to correct the product identifiers and to report that the provided medical device lot # does not correspond to the device implanted in the patient.Upon further review, it was noted that the patient was implanted with the 3dmax light in 2022; however, the medical device lot # provided was manufactured in 2024.It was identified that the provided medical device lot # does not correspond to the device implanted in the patient on 2022.Updated fields: b4, g3, g6, h2, h6, h10, h11.Corrected fields: d4 (medical device catalog/lot/expiration date and udi) addendum 2: h11: this is an addendum to the previously submitted mdrs.This mdr (ref.No.1213643-2026-00194) was identified as duplicate of a previously submitted mdr, (ref.No.1213643-2025-01111).As such, this supplemental emdr is submitted to report the information.Any additional information received regarding this patient will be submitted under ref.No.1213643-2025-01111.Updated fields: b4, g3, g6, h2, h10, h11.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
As reported, in (b)(6) 2022 the patient underwent a hernia repair procedure and was implanted with a 3dmax light mesh.It was reported that since the procedure the patient has been experiencing inflammatory symptoms, fibrosis and chronic abdominal/back pain.

• 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: 24412843
• Report Number: 1213643-2026-00194
• Device Sequence Number: 10608446
• Product Code: FTL
• UDI-Device Identifier: 00801741031038
• UDI-Public: (01)00801741031038(17)290428(10)HUJS0274
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K091659
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 03/11/2026

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 Catalogue Number: UNKAA002
• Device Lot Number: HUJS0274
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/04/2026
• Supplement Date Received by Manufacturer: 02/25/2026; 03/10/2026
• Initial Report FDA Received Date: 02/23/2026
• Supplement Report FDA Received Date: 03/03/2026; 03/12/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/26/2024
• 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: Other
• Patient Sex: Male