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

Catalog Number	0117320
Medical Device Problem Code	Patient-Device Incompatibility (2682)
Health Effect - Clinical Codes	Emotional Changes (1831); Pain (1994); Scar Tissue (2060); Injury (2348)
Date of Event	05/15/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
At this time no conclusions can be made.The patient's attorney alleges past, present and future damages, pain and suffering and permanent injury, 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 3d max light (device #2).An additional emdr was submitted to represent the bard/davol 3d max mesh (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 an unspecified bard/davol 3d max and an unspecified bard/davol 3d max light on (b)(6) 2018.It is alleged the patient had unspecified injuries on (b)(6) 2019.As reported, the patient is making a claim for an adverse patient outcome against both the devices.As reported, the attorney alleges general allegations for "past, present, and future damages, including but not limited to, mental and physical pain and suffering for severe and permanent personal injuries sustained by the patient." attorney alleges that the patient experienced emotional distress and the device was defective.
Event or Problem Description
Attorney alleges that the patient underwent surgery for implant of an unspecified bard/davol 3d max and an unspecified bard/davol 3d max light on (b)(6) 2018.It is alleged the patient had unspecified injuries on (b)(6) 2019.As reported, the patient is making a claim for an adverse patient outcome against both the devices.As reported, the attorney alleges general allegations for "past, present, and future damages, including but not limited to, mental and physical pain and suffering for severe and permanent personal injuries sustained by the patient." 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 large right indirect inguinal hernia, left pantaloon inguinal hernia thereby underwent laparoscopic repair with the implant of 3dmax mesh (left ¿ device 1), 3dmax light mesh (right ¿ device 2).Per op notes, ¿on left side, a direct and indirect hernia defects containing preperitoneal fat were noted.A medium sized 3dmaxt mesh (device 1 was placed to cover indirect and direct spaces and secured with tacks to iliopubic tract.On right side, a large indirect hernia sac with scrotal component was identified.A large 3dmax light mesh (device 2) was place and fixated with tacks to iliopubic tract.¿ (b)(6) 2019 ¿ patient had pain and was diagnosed with left recurrent inguinal hernia thereby underwent robotic assisted repair with the removal of tacks.Per op notes, ¿on right, the plane was developed between the inferior edge of the mesh (device 2) and peritoneum.Ample scar tissue was noted.The lateral tacks were removed from portion of mesh (device 2) tacked down to iliopubic tract.On left, direct space had a fat containing hernia was reduced.The mesh (device 1) was found to be folded down.A synthetic mesh was placed into preperitoneal space using sutures.¿ (b)(6) 2019 ¿ patient had pain in right groin thereby provided medications.
Additional Manufacturer Narrative
At this time no conclusions can be made.The patient's attorney alleges past, present and future damages, pain and suffering and permanent injury, 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-dec-2017) is considered to be a best estimate.Updated fields: a2, a4, b2, b4, b5, b6, b7, d4 (product catalog no., corporate lot no., expiry date, udi no.), g3, g6, h2, h4, h6, h10.This supplemental emdr represents the bard/davol - 3dmax light mesh (device 2).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.

• 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: 9412798
• Report Number: 1213643-2019-11724
• Device Sequence Number: 448463
• Product Code: FTL
• UDI-Device Identifier: 00801741031052
• UDI-Public: (01)00801741031052(17)221228(10)HUBZ0794
• Combination Product (Y/N): N
• Initial Reporter State: RI
• Initial Reporter Country: US
• PMA/510(K) Number: K091659
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: Other,Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/04/2025

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: 12/28/2022
• Device Catalogue Number: 0117320
• Device Lot Number: HUBZ0794
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/26/2019
• Supplement Date Received by Manufacturer: 10/15/2025
• Initial Report FDA Received Date: 12/04/2019
• Supplement Report FDA Received Date: 11/04/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 12/15/2017
• 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: Disability; Required Intervention
• Patient Age: 58 YR
• Patient Sex: Male
• Patient Weight: 93 KG