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

Catalog Number	0115322
Medical Device Problem Codes	Defective Device (2588); Patient-Device Incompatibility (2682); Patient Device Interaction Problem (4001)
Health Effect - Clinical Codes	Pain (1994); Insufficient Information (4580)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
No conclusions can be made.The patient's attorney alleges adverse patient outcome associated with the hernia mesh used to treat the patient.The patient's attorney alleges that the patient had subsequent surgical intervention; however, no details have been provided.No lot number has been provided; therefore, a review of the manufacturing records is not possible.This emdr represents the bard/davol 3dmax (device #2).An additional emdr was submitted to represent the bard/davol 3dmax (device #1).Should additional information be provided, a supplemental emdr will be submitted.Not returned.
Event or Problem Description
Attorney alleges that the patient underwent surgery for implant of unspecified bard/davol 3dmax mesh on (b)(6) 2018 and (b)(6) 2019.As reported, the patient is making a claim for an adverse patient outcome against both the devices.It is alleged that the patient had subsequent surgical intervention due to the hernia mesh device.Attorney alleges that the patient experienced emotional distress and the device was defective.
Additional Manufacturer Narrative
No conclusions can be made.The patient's attorney alleges adverse patient outcome associated with the hernia mesh used to treat the patient.The patient's attorney alleges that the patient had subsequent surgical intervention; however, no details have been provided.No lot number has been provided; therefore, a review of the manufacturing records is not possible.Addendum: this supplemental emdr is submitted to document additional information provided.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.Updated fields: a2, b3, b4, b5, b7, d4 (product catalog no., udi no.), g3, g6, h2, h6, h10.This supplemental emdr represents the bard/davol¿ 3dmax mesh (device #3).An additional supplemental emdr was submitted to represent the bard/davol - 3dmax mesh (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.H3 other text : not returned.
Event or Problem Description
Attorney alleges that the patient underwent surgery for implant of unspecified bard/davol 3dmax mesh on (b)(6) 2018 and (b)(6) 2019.As reported, the patient is making a claim for an adverse patient outcome against both the devices.It is alleged that the patient had subsequent surgical intervention due to the hernia mesh device.Attorney alleges that the patient experienced emotional distress and the device was defective.Addendum per additional information provided: (b)(6) 2018 ¿ patient was diagnosed with bilateral inguinal hernia thereby underwent robotic repair with the robotic repair with the implant of 3dmax mesh (device #1 ¿ right, device #2 ¿ left).Per op notes, ¿a very large right sided inguinal hernia defect was noted and large right sided 3dmax mesh (device #1) was placed to cover indirect and direct defect using sutures.On left, a large 3dmax mesh (device #2) was placed on the indirect defect using sutures.¿ (b)(6) 2019 ¿ patient was diagnosed with recurrent right inguinal hernia thereby underwent robotic repair with the implant of 3dmax mesh (device #3).Per op notes, ¿right anal hernia defect was identified.The previously placed mesh (device #1) was blown out through defect and inferolateral edge of the mesh, rolled on itself and herniated through the indirect hernia defect, densely adherent to the spermatic cord.An extra large 3dmax mesh (device #3) was used to cover the hernia repair using sutures.¿.

• Brand Name: 3DMAX
• 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 ; 4018258495
• MDR Report Key: 12867078
• Report Number: 1213643-2021-08876
• Device Sequence Number: 3708263
• Product Code: FTL
• UDI-Device Identifier: 00801741030772
• UDI-Public: (01)00801741030772
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K081010
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: Other,Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/25/2025

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: 0115322
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/19/2021
• Supplement Date Received by Manufacturer: 07/07/2025
• Initial Report FDA Received Date: 11/24/2021
• Supplement Report FDA Received Date: 07/25/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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 Sex: Male