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

Catalog Number	0117311
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Neuropathy (1983); Seroma (2069); Hernia (2240)
Date of Event	07/01/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Based on the contents of the article, no conclusions can be made.The information provided in the article indicates that some patients experienced post operative complications.The information obtained is limited to the content of the article.The article does not report any specific device malfunction or post-op complications were caused or contributed to the use of the 3dmax light mesh.The adverse reaction section of the instructions-for-use (ifu), supplied with the device identifies seroma and hernia recurrence as possible complications.No lot number has been provided; therefore, a review of the manufacturing records is not possible.Note, the date of event (b)(6) 2018) is considered to be a best estimate.This record represents the 3dmax light large (left).An additional mdr has been submitted to represent the 3dmax light large (right).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
Per journal article: "analysis of learning curve of laparoscopic trans abdominal preperitoneal (tapp) inguinal hernia repair".This retrospective study evaluates laparoscopic transabdominal preperitoneal (tapp) inguinal hernia repair performed by single surgeon in 55 patients (53 males and 2 females).The study included a total of 79 repairs, including 31 unilateral and 24 bilateral cases between july 2018 and january 2020.Hernia types included direct (n=50), indirect (n=23), and combined (n=6), with some recurrent cases (n=3).A bard 3dmax light polypropylene mesh (10 x 16 cm) was used in all cases, positioned with adequate overlap and fixed using a single tack at cooper's ligament, followed by peritoneal closure with 3-0 prolene.Postoperatively, complications included seroma (n=7) particularly in patients with large hernia sacs.Two patients (n=2) developed neuropathy.One patient complained of chronic pricking type of inguinal pain, while the other developed numbness over the lateral aspect of groin and thigh (meralgia).There was one medial recurrence (n=1) noted during the follow up period in a patient who had a large hernial sac with both direct and indirect components.The article concludes that the tapp inguinal hernia repair demonstrates a relatively short learning curve, with operative time stabilizing after about 16 cases.The technique is safe and effective, with low rates of major complications and recurrence comparable to reported tep outcomes.These findings support tapp as an accessible and reliable option, particularly for large or complex hernias.Note: there is no information provided in the article indicating that the device caused or contributed to the postoperative patient complication(s).However, as postoperative complications did present and some requiring medical/surgical intervention we are reporting this as a serious injury mdr.This file represents 3dmax light (left).

• 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 ; 8005566756
• MDR Report Key: 25753647
• Report Number: 1213643-2026-00882
• Device Sequence Number: 10449541
• Product Code: FTL
• UDI-Device Identifier: 00801741031038
• UDI-Public: (01)00801741031038
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• PMA/510(K) Number: K091659
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Literature,Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 06/30/2026

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 Catalogue Number: 0117311
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/25/2026
• Initial Report FDA Received Date: 07/08/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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: Other
• Patient Sex: Unknown