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

Catalog Number	0117320
Medical Device Problem Codes	Defective Device (2588); Insufficient Device Problem Information (3190); Migration (4003)
Health Effect - Clinical Codes	Hernia (2240); Injury (2348)
Date of Event	09/01/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
At this time no conclusions can be made regarding the bard/davol 3dmax light (device #1) used to treat the patient.The patient's attorney did allege 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 #1).The patient's attorney did not make any allegations regarding the implanted bard/davol perfix plug device.Should additional information be provided a supplemental emdr will be submitted.Not returned.
Event or Problem Description
Attorney alleges that on (b)(6) 2016, the patient underwent surgery for implant of an unspecified bard/davol 3dmax light mesh (device #1) and an unspecified bard/davol perfix plug.It is alleged that the patient had subsequent surgical intervention due to the hernia mesh device.As reported, the patient is only making a claim for an adverse patient outcome against the 3dmax light mesh (device #1).As reported, the attorney alleges product is defective and that the patient experienced emotional distress.
Additional Manufacturer Narrative
At this time no conclusions can be made regarding the bard/davol 3dmax light (device #1) used to treat the patient.The patient's attorney did allege 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 #1).The patient's attorney did not make any allegations regarding the implanted bard/davol perfix plug device.Should additional information be provided a supplemental emdr will be submitted.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.H11: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.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-may-2016) is considered to be a best estimate.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 on (b)(6) 2016, the patient underwent surgery for implant of an unspecified bard/davol 3dmax light mesh (device #1) and an unspecified bard/davol perfix plug.It is alleged that the patient had subsequent surgical intervention due to the hernia mesh device.As reported, the patient is only making a claim for an adverse patient outcome against the 3dmax light mesh (device #1).As reported, the attorney alleges product is defective and that the patient experienced emotional distress.Addendum per additional information provided: (b)(6) 2016 - patient was diagnosed with right inguinal hernia thereby underwent laparoscopic repair with the implant of 3dmax light mesh (device #1).Per op notes, ¿a 3dmax light mesh (device #1) was placed to the cooper¿s ligament using sutures.¿ (b)(6) 2017 - patient was diagnosed with recurrent right inguinal hernia thereby underwent open repair with the implant of perfix light plug (device #2).Per op notes, ¿the mesh (device #1) was incorporated and migrated laterally.A perfix light plug (device #2) was placed to the internal ring and patch was placed over the posterior wall using prolene sutures to the pubic tubercle.¿.

• 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: 9384403
• Report Number: 1213643-2019-11558
• Device Sequence Number: 469643
• Product Code: FTL
• UDI-Device Identifier: 00801741031052
• UDI-Public: (01)00801741031052(17)210528(10)HUAS0441
• 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): 06/10/2025

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: 05/28/2021
• Device Catalogue Number: 0117320
• Device Lot Number: HUAS0441
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/15/2019
• Supplement Date Received by Manufacturer: 05/28/2025
• Initial Report FDA Received Date: 11/27/2019
• Supplement Report FDA Received Date: 06/10/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/15/2016
• 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: 64 YR
• Patient Sex: Male