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	Pain (1994); Seroma (2069); Hernia (2240); Wound Infection (2447)
Date of Event	01/01/2016
Type of Reportable Event	Serious Injury
Event or Problem Description
Per journal article: risk factors and clinical impact of seroma formation following laparoscopic inguinal hernia repair: a retrospective study.This study aimed to investigate the risk factors and clinical outcomes of seroma formation in patients undergoing lihr.Cases were performed from january 2016 to march 2023, clinical data of patients who underwent lihr were retrospectively analyzed.Patients who developed seroma and those who did not were classified into the seroma and non-seroma groups, respectively.A total of 128 patients were evaluated and underwent surgery in same hospital.All the patients underwent lihr with implant of 3dmax light mesh (10.3 × 15.7 cm) in which 30 patients using 3dmax light mesh, left and 88 patients using 3dmax light mesh, right and 10 patients underwent bilateral.This study revealed a higher incidence of seromas in the tep group than in the tapp group.Seroma group - 2 patient had postoperative fever, nrs of postoperative pain, 1 patient have wound infection, and 1 patient had recurrence.For non-seroma group - 6 patient had postoperative fever, nrs of postoperative pain, 2 patients have wound infection.This article concludes bmi, hernial orifice size, tep and psal were independent risk factors of postoperative seroma formation in patients who underwent lihr.Although most seromas resolve spontaneously without surgical intervention, seroma formation results in increased patient pain and prolonged hospital stay.Expectant treatment with observation is plausible in small seromas, which are mostly absorbed within 3 months.However, several symptomatic seromas require postoperative surgical drainage.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.
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, supplied with the device identifies seroma, infections, pain 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 (01-jan-2016) 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 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.

• 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: 23084928
• Report Number: 1213643-2025-00874
• Device Sequence Number: 16073448
• 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; Hospitalization
• Patient Sex: Unknown