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

Catalog Number	0117310
Health Effect - Clinical Codes	Hernia (2240); Injury (2348)
Date of Event	07/05/2017
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.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 3dmax light mesh on (b)(6) 2017.As reported, the patient is making a claim for an adverse patient outcome against the 3dmax light mesh.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 and the device was defective.
Event or Problem Description
Attorney alleges that the patient underwent surgery for implant of an unspecified bard/davol 3dmax light mesh on (b)(6) 2017.As reported, the patient is making a claim for an adverse patient outcome against the 3dmax light mesh.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 and the device was defective.Addendum per additional information provided: (b)(6) 2017 - patient was diagnosed with bilateral inguinal hernias thereby underwent open repair with the implant of two 3dmax light meshes (device 1 and device 2).Per op notes, "a.Large indirect left inguinal hernia was identified, and a smaller right inguinal hernia was also identified.Two 3dmax light meshes (device 1 - left and device 2 - right) were placed into the anterior abdominal wall on either sides of the epigastric vessels." (b)(6) 2017 - patient was diagnosed with recurrent left inguinal hernia thereby underwent robotic repair with the removal of mesh (device 1).Per op notes, "a left inguinal hernia defect which was recurrent.No significant defect was found on the right side.On the left side, a piece of mesh (device 1) was cut on the cranial and medial side of the cord structures." (b)(6) 2020 - patient was diagnosed with recurrent left inguinal hernia thereby underwent open lichtenstein tension-free repair with synthetic mesh.
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: h11: this supplemental emdr is submitted to document additional information provided and to correct the product catalog no.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-sep-2016) is considered to be a best estimate.Updated fields: a2,a4,b3,b4,b5,b7,d3,d4(product catalog no., udi no, expiry date, corporate lot no),d.6b (date of explant), g3,g6,h2,h4,h6,h10.Corrected field: d4 (product catalog no.), 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: 11337339
• Report Number: 1213643-2021-01081
• Device Sequence Number: 17276246
• Product Code: FTL
• UDI-Device Identifier: 00801741031021
• UDI-Public: (01)00801741031021(17)210928(10)HUAW2063
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K091659
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: Other,Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/16/2025

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: 09/28/2021
• Device Catalogue Number: 0117310
• Device Lot Number: HUAW2063
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/16/2021
• Supplement Date Received by Manufacturer: 09/24/2025
• Initial Report FDA Received Date: 02/17/2021
• Supplement Report FDA Received Date: 10/16/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/15/2016
• 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: 71 YR
• Patient Sex: Male
• Patient Weight: 82 KG