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); Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Pain (1994); Injury (2348)
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.Should additional information be provided a supplemental emdr will be submitted.This emdr represents the bard/davol 3dmax light (device #1).An additional emdr was submitted to represent the bard/davol perfix plug (device #2).Not returned.
Event or Problem Description
Attorney alleges that the patient underwent surgery for implant of an unspecified bard/davol 3dmax light mesh (device #1) or an unspecified bard/davol perfix plug (device #2) on (b)(6) 2018.It is alleged that the patient had subsequent surgical intervention due to the hernia mesh device(s).As reported, the patient is making a claim for an adverse patient outcome against the bard/davol 3dmax light mesh (device #1) and the perfix plug (device #2).As reported, the attorney alleges patient experienced emotional distress and the device was defective.
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.Should additional information be provided a supplemental emdr will be submitted.This emdr represents the bard/davol 3dmax light (device # 1).An additional emdr was submitted to represent the bard/davol perfix plug (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.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-oct-2017) 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 the patient underwent surgery for implant of an unspecified bard/davol 3dmax light mesh (device # 1) or an unspecified bard/davol perfix plug (device # 2) on (b)(6) 2018.It is alleged that the patient had subsequent surgical intervention due to the hernia mesh device(s).As reported, the patient is making a claim for an adverse patient outcome against the bard/davol 3dmax light mesh (device # 1) and the perfix plug (device # 2).As reported, the attorney alleges patient experienced emotional distress and the device was defective.Addendum per additional information provided: on (b)(6) 2018 - patient was diagnosed with right inguinal hernia thereby underwent open repair with the implant of perfix plug (device #1).Per operative notes, "the hernia was noted and reduced.A perfix plug was placed and tacked to the floor.An onlay patch was tacked to pubic tubercle." on (b)(6) 2018 - patient was diagnosed with bilateral inguinal pain and bilateral inguinal hernia thereby underwent laparoscopic inguinal hernia repair with the implant of 3dmax light meshes (device # 2, # 3), resection of nerve and removal of mesh (device # 1).Per operative notes, "the nerves were entrapped beneath the mesh.The previous mesh (device # 1) was removed completely.Two 3dmax light meshes (device # 2, # 3) were placed on both sides ad sutured.".

• 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: 9246921
• Report Number: 1213643-2019-10309
• Device Sequence Number: 16657795
• Product Code: FTL
• UDI-Device Identifier: 00801741031045
• UDI-Public: (01)00801741031045(17)221028(10)HUBX1887
• Combination Product (Y/N): N
• Initial Reporter State: KS
• 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): 06/13/2025

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: 10/28/2022
• Device Catalogue Number: 0117312
• Device Lot Number: HUBX1887
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/16/2019
• Supplement Date Received by Manufacturer: 05/28/2025
• Initial Report FDA Received Date: 10/28/2019
• Supplement Report FDA Received Date: 06/13/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/15/2017
• 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: Required Intervention
• Patient Sex: Male
• Patient Weight: 63 KG