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

Catalog Number	0116322
Medical Device Problem Code	Patient-Device Incompatibility (2682)
Health Effect - Clinical Codes	Fatigue (1849); Discomfort (2330)
Date of Event	01/24/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
As reported, the patient had an allergic reaction (fatigue, joint tenderness and discomfort in the groin area) post implant of 3dmax mid.A mesh sample has been provided to the doctor to perform reactivity testing and reportedly the test is scheduled on (b)(6) 2025.At this time, no conclusion can be made.If/when reactivity test results are provided, a supplemental mdr will be submitted.The adverse reactions section of the instructions-for-use supplied with the device list allergic reaction as a possible complication.Review of manufacturing records confirms the product was manufactured to specification.To date, this is the only reported complaint for this manufacturing lot of 663 units.This mdr represents the 3dmax mid (device #2).An additional mdr was submitted to represent the 3dmax mid (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.
Event or Problem Description
As reported, patient underwent a bilateral inguinal hernia repair with the implant of 3dmax mid meshes (device #1 - left & device #2 - right) on (b)(6) 2024 and experienced allergic reaction post implant.It was reported that patient experienced symptoms of fatigue, joint tenderness and discomfort in the groin area where the meshes were placed and no treatment was provided to the patient currently.It was also reported that the surgeon is planning to perform a reactivity test with the 3dmax mid mesh sample on (b)(6) 025.This file represents device #2.
Additional Manufacturer Narrative
As reported, the patient had an allergic reaction (fatigue, joint tenderness and discomfort in the groin area) post implant of 3dmax mid.A mesh sample has been provided to the doctor to perform reactivity testing and reportedly the test is scheduled on (b)(6) 2025.At this time, no conclusion can be made.If/when reactivity test results are provided, a supplemental mdr will be submitted.The adverse reactions section of the instructions-for-use supplied with the device list allergic reaction as a possible complication.Review of manufacturing records confirms the product was manufactured to specification.To date, this is the only reported complaint for this manufacturing lot of 663 units.Addendum: this is an addendum to the initial mdr submitted.This supplemental mdr is submitted to document the reactivity test results.Reactivity testing has been performed and as reported the results were negative for a reaction to the mesh sample.It is unknown at this time, what is causing the patient's condition.However, based on testing performed the postoperative conditions experienced by the patient do not appear to be caused by the 3dmax mid mesh used to treat the patient.This supplemental emdr (1213643-2025-00046) represents the 3dmax mid (device #2).An additional supplemental emdr (1213643-2025-00045) was submitted to represent the 3dmax mid (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.
Event or Problem Description
As reported, patient underwent a bilateral inguinal hernia repair with the implant of 3dmax mid meshes (device #1 - left & device #2 - right) on (b)(6) 2024 and experienced allergic reaction post implant.It was reported that patient experienced symptoms of fatigue, joint tenderness and discomfort in the groin area where the meshes were placed and no treatment was provided to the patient currently.It was also reported that the surgeon is planning to perform a reactivity test with the 3dmax mid mesh sample on (b)(6) 2025.Addendum: the mesh sample was applied to the patient on (b)(6) 2025 for reactivity testing.The final reading was on (b)(6) 2025 and showed no reaction to the 3dmax mid mesh.Doctor advised patient to leave mesh in place, as her symptoms are not related to the mesh.This file represents device #2.

• Brand Name: 3DMAX MID
• 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: 21371240
• Report Number: 1213643-2025-00046
• Device Sequence Number: 3849736
• Product Code: FTL
• UDI-Device Identifier: 00801741200793
• UDI-Public: (01)00801741200793(17)281028(10)HUHY0107
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K200818
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Reporter Type: Manufacturer
• Report Source: Other,User Facility
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/11/2025

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: 0116322
• Device Lot Number: HUHY0107
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/24/2025
• Supplement Date Received by Manufacturer: 03/10/2025
• Initial Report FDA Received Date: 02/13/2025
• Supplement Report FDA Received Date: 03/14/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 12/11/2023
• 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: 47 YR
• Patient Sex: Female