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

Catalog Number	0115312
Medical Device Problem Codes	Defective Device (2588); Patient-Device Incompatibility (2682); Patient Device Interaction Problem (4001)
Health Effect - Clinical Codes	Adhesion(s) (1695); Pain (1994); Hernia (2240); Obstruction/Occlusion (2422); 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 #1).An additional emdr was submitted to represent the bard/davol 3dmax (device #2).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 two unspecified bard/davol 3dmax meshes on (b)(6) 2006 and (b)(6) 2011.As reported, the patient is making a claim for an adverse patient outcome against both devices.It is alleged that the patient had subsequent surgical intervention due to the hernia mesh device.It is also alleged that the patient had personal injury, 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.This supplemental emdr represents the 3dmax (device #1).An additional supplemental emdr was submitted to represent the 3dmax (device #2).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
Attorney alleges that the patient underwent surgery for implant of two unspecified bard/davol 3dmax meshes on (b)(6) 2006 and (b)(6) 2011.As reported, the patient is making a claim for an adverse patient outcome against both devices.It is alleged that the patient had subsequent surgical intervention due to the hernia mesh device.It is also alleged that the patient had personal injury, experienced emotional distress and the device was defective.Addendum per additional information provided: (b)(6) 2006 ¿ patient was diagnosed with left inguinal hernia thereby underwent laparoscopic repair with the implant of 3dmax mesh (device #1).Per op notes, ¿there was a direct and indirect hernia.A bard extra large left-sided 3dmax mesh (device #1) was placed in the preperitoneal space and positioned to cover the direct space, the indirect space and the femoral space and tacked.¿ (b)(6) 2011 ¿ patient was diagnosed with right inguinal hernia thereby underwent laparoscopic repair with the implant of 3dmax mesh (device #2).Per op notes, ¿there was a direct and indirect hernia.The large right-sided 3dmax mesh (device #2) was positioned to cover the direct space, the indirect space and the femoral space and tacked to the symphysis pubis and anterior abdominal wall using absorbable tacks.¿.

• 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: 11812339
• Report Number: 1213643-2021-03416
• Device Sequence Number: 11699311
• Product Code: FTL
• UDI-Device Identifier: 00801741030741
• UDI-Public: (01)00801741030741(10)43IQD026
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K081010
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2006
• Reporter Type: Manufacturer
• Report Source: Other,Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/17/2025

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: 0115312
• Device Lot Number: 43IQD026
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/29/2021
• Supplement Date Received by Manufacturer: 05/27/2025
• Initial Report FDA Received Date: 05/12/2021
• Supplement Report FDA Received Date: 06/17/2025
• 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