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

Catalog Number	0117312
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 light (device #2).Additional emdrs were submitted to represent the bard/davol 3dmax (device #1) and the bard/davol perfix plug (device #3).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, 3dmax light mesh and perfix plug on (b)(6) 2015 and/or (b)(6) 2016.As reported, the patient is making a claim for an adverse patient outcome against all devices.Attorney alleges that the patient had subsequent surgical intervention due to the hernia mesh device.It is also alleged that the patient experienced emotional distress, sustained personal injury and the device was defective.
Event or Problem Description
Attorney alleges that the patient underwent surgery for implant of unspecified bard/davol 3dmax mesh, 3dmax light mesh and perfix plug on (b)(6) 2015 and/or (b)(6) 2016.As reported, the patient is making a claim for an adverse patient outcome against all devices.Attorney alleges that the patient had subsequent surgical intervention due to the hernia mesh device.It is also alleged that the patient experienced emotional distress, sustained personal injury and the device was defective.Addendum per additional information provided: (b)(6) 2015 - patient was diagnosed with recurrent left inguinal hernia thereby underwent laparoscopic repair with the implant of perfix plug (device #1).Per op notes, "an incision was made in the left groin, a perfix plug (device #1) was placed." (b)(6) 2016 - patient was diagnosed with recurrent bilateral inguinal hernia thereby underwent laparoscopic repair with the removal of mesh (device #1) and implant of a 3dmax light mesh (device #2) & 3dmax mesh (device #3).Per op notes, "in the left, patient noted to have a mesh placed in the internal ring, this was dissected away from the hernia defect.A 3dmax light mesh (device #2) was placed in the preperitoneal space and tacked to the pubis.Attention was turned to the right, a 3dmax mesh (device #3) was placed in the preperitoneal space and tacked to the pubis.".
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.Note, the manufacturing date (15-jun-2015) is considered to be a best estimate.Updated fields: a2, b4, b5, b7, d3, d4 (product catalog no., udi no., expiry date, corporate lot no.), d.6a (date of implant), g3, g6, h2, h4, h6, h10.This supplemental emdr represents the bard/davol 3dmax light (device #2).Additional supplemental emdrs were submitted to represent the bard/davol 3dmax (device #3) and the bard/davol perfix plug (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.

• 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 ; 4018258495
• MDR Report Key: 12416204
• Report Number: 1213643-2021-07344
• Device Sequence Number: 14346710
• Product Code: FTL
• UDI-Device Identifier: 00801741031045
• UDI-Public: (01)00801741031045(17)200628(10)HUZF1679
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K091659
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Reporter Type: Manufacturer
• Report Source: Other,Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/07/2025

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 Expiration Date: 06/28/2020
• Device Catalogue Number: 0117312
• Device Lot Number: HUZF1679
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/27/2021
• Supplement Date Received by Manufacturer: 07/16/2025
• Initial Report FDA Received Date: 09/02/2021
• Supplement Report FDA Received Date: 08/07/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/15/2015
• 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