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

Catalog Number	0117321
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Hematoma (1884); Seroma (2069); Swelling/ Edema (4577)
Date of Event	06/01/2021
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 of seroma, edema and hematoma.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.Seroma and hematoma are labeled side effects that are considered foreseeable and clinically acceptable in terms of patient benefit.No lot number has been provided; therefore, a review of the manufacturing records is not possible.Note, the date of event (01-jun-2021) is considered to be a best estimate.This report documents information related to the 3dmax light mesh (cat no.0117321).An additional mdr has been submitted to document information related to another 3dmax light mesh (cat no.0117311).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: preliminary experience in using the lateral single-incision laparoscopic totally extraperitoneal approach for inguinal hernia repair.The aim of the study is to evaluate the feasibility, safety, and efficacy of the lateral single-incision laparoscopic totally extraperitoneal (l-siltep) approach in patients with inguinal hernia who had contraindications to the midline approach.This study included 58 patients who underwent surgery using the l-siltep approach for inguinal hernia repair between june 2021 and april 2023.There were 37 patients underwent hernia repair using bard 3dmax mesh (10 x 15 cm) right large and 21 patients using bard 3dmax mesh (10 x 15 cm) left large lightweight polypropylene mesh without fixation.Five (8.6%) patients experienced postoperative complications (seroma, n = 3; preperitoneal space hematoma, n = 1; and scrotal edema, n = 1).No hernia recurrence or incisional hernia was observed over a mean follow-up duration of 16 (6-25) months.This procedure provides a clearer perspective for assessing the positional association between the hernia sac and the spermatic cord, offering a more ergonomic operating angle during sac dissection.Lateral single-incision laparoscopic totally extraperitoneal (l-siltep) approach can be used for patients with contraindications to the midline approach.Furthermore, it is a safe and effective procedure.This technical advantage is particularly beneficial for managing scrotal 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.

• 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: 23084923
• Report Number: 1213643-2025-00869
• Device Sequence Number: 10503043
• Product Code: FTL
• UDI-Device Identifier: 00801741031069
• UDI-Public: (01)00801741031069
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K091659
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Literature
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 09/05/2025

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 Catalogue Number: 0117321
• 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: 09/03/2025
• Initial Report FDA Received Date: 09/18/2025
• 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: Required Intervention
• Patient Sex: Unknown