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	Abdominal Pain (1685); Hypersensitivity/Allergic reaction (1907); Inflammation (1932); Fibrosis (3167); Back pain (4895)
Date of Event	09/28/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
As reported, on (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 significant tolerance/allergy issues, including fibrosis and a reaction in the operated area.
Additional Manufacturer Narrative
As reported, the patient has tolerance/allergy problems, including fibrosis and a reaction in the operative area post implant of a 3dmax light mesh.No conclusions can be made.The degree to which the 3dmax light mesh implant used to treat the patient, may be causing, or contributing to the ongoing symptoms is unknown.Based on the information provided it is unclear what is causing the reported allergic reaction and fibrosis.A review of the manufacturing records was performed and found the lot was manufactured to specification.To date, this is the only reported complaint for this manufacturing lot of 1,344.Allergic reaction is listed as a possible complication in the adverse reactions section of the instructions-for-use, provided with the device.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, on (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 significant tolerance/allergy issues, including fibrosis and a reaction in the operated area.Addendum: as reported, the patient did not go under any medication or treatment, and the doctor is considering starting a desensitization treatment.Reportedly, since the procedure the patient has been experiencing inflammatory symptoms, fibrosis and chronic abdominal/back pain.
Additional Manufacturer Narrative
As reported, the patient has tolerance/allergy problems, including fibrosis and a reaction in the operative area post implant of a 3dmax light mesh.No conclusions can be made.The degree to which the 3dmax light mesh implant used to treat the patient, may be causing, or contributing to the ongoing symptoms is unknown.Based on the information provided it is unclear what is causing the reported allergic reaction and fibrosis.A review of the manufacturing records was performed and found the lot was manufactured to specification.To date, this is the only reported complaint for this manufacturing lot of 1,344.Allergic reaction is listed as a possible complication in the adverse reactions section of the instructions-for-use, provided with the device.Addendum: this is an addendum to the initial mdr submitted to document the additional information provided.Based on the addition information, since the implantation of 3dmax light mesh the patient has been experiencing inflammatory symptoms, fibrosis and chronic abdominal/back pain.Based on the additional information received, 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 allergic reaction, pain and inflammation as possible complications.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: 23616299
• Report Number: 1213643-2025-01111
• Device Sequence Number: 8968637
• Product Code: FTL
• UDI-Device Identifier: 00801741031038
• UDI-Public: (01)00801741031038(17)270328(10)HUGR1551
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K091659
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Consumer,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/13/2026

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: 0117311
• Device Lot Number: HUGR1551
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/30/2025
• Supplement Date Received by Manufacturer: 03/10/2026
• Initial Report FDA Received Date: 11/21/2025
• Supplement Report FDA Received Date: 03/19/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/26/2022
• 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: 28 YR
• Patient Sex: Male