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	Hematoma (1884); Seroma (2069)
Date of Event	04/01/2022
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 hematoma 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-apr-2022) is considered to be a best estimate.This mdr represents the 3dmax light mesh (left).An additional mdr has been submitted to document information related to the 3dmax light mesh (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: "comparison of single-incision totally extraperitoneal repair of inguinal hernia and conventional multi-port totally extraperitoneal repair: a retrospective study".This retrospective single-center study evaluated the feasibility, safety, and clinical outcomes of single-incision totally extraperitoneal repair (sils-tep) compared with conventional three-port tep repair for inguinal hernia treatment.A total of 102 patients who underwent tep repair between (b)(6) 2022 and (b)(6) 2025 were included.The study assessed operative time, postoperative pain, complications, chronic pain, recurrence, and hospitalization outcomes.The study included 102 patients (62 patients underwent sils-tep and 40 patients underwent conventional three-port tep).The mean age was 66 years in the sils-tep group and 68 years in the three-port tep group.Most patients were male (87% and 93%, respectively).Both groups had comparable baseline characteristics and hernia classifications.All patients underwent laparoscopic totally extraperitoneal (tep) inguinal hernia repair under general anesthesia.Site included unilateral and bilateral.In the sils-tep group, surgery was performed through a single approximately 2-cm umbilical incision using a lap protector and ez access platform containing three 5-mm ports.In the three-port tep group, one 12-mm port and two 5-mm ports were inserted sequentially through separate incisions.For indirect hernias, the hernia sac was closed using a roeder's knot.In both groups, 3dmax light mesh large was placed in the extraperitoneal space to adequately cover the myopectineal orifice.The mesh was positioned carefully during deflation of the extraperitoneal space to prevent inversion.No specific mesh fixation technique was described.The major difference between the groups was the number of access incisions and port placement technique, while the same mesh type and tep repair principles were used in both groups.Post operative complication include (1) peritoneal injury requiring repair occurred in 6 patients (4 in sils-tep and 2 in tep group), these injuries were managed intraoperatively with endoscopic suturing repair.(2) seroma: 6 cases (9.7%) in sils-tep and 4 cases (10.0%) in three-port tep.(3) hematoma: 1 case (1.6%) in sils-tep and 1 case (2.5%) in three-port tep.It is concluded that sils-tep is a safe and feasible alternative to conventional three-port tep repair, providing equivalent clinical outcomes with a significantly shorter operative time and improved cosmetic results.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: 25758013
• Report Number: 1213643-2026-00878
• Device Sequence Number: 9787285
• Product Code: FTL
• UDI-Device Identifier: 00801741031038
• UDI-Public: (01)00801741031038
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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: 07/09/2026
• 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