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

Catalog Number	0117321
Medical Device Problem Code	Patient-Device Incompatibility (2682)
Health Effect - Clinical Code	Hernia (2240)
Date of Event	08/09/2011
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
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-jun-2010) is considered to be a best estimate.This mdr represents the 3dmax light mesh (device 2).An additional supplemental emdr was submitted to represent the 3dmax light mesh (device 1).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 information provided: on (b)(6) 2010: patient was diagnosed with bilateral inguinal hernia and right groin pain thereby underwent laparoscopic repair with implant of two 3dmax light meshes (device 1 and 2).Per operative notes, ¿in the left groin, a large sac in the direct space was noted and reduced completely.A large 3dmax light mesh (device 1) was placed over the defect in the left side and tacked.In the right groin area, a large direct hernia was dissected free from the direct space and another 3dmax light mesh (device 2) was placed over the defect and sutured circumferentially.¿ on (b)(6) 2011: patient was diagnosed with recurrent left inguinal hernia thereby underwent open repair with implant of perfix plug (device 3).Per operative notes, ¿a small sac with cord lipoma was dissected from the inguinal canal contents.A large direct component to inguinal hernia was reduced back within abdominal cavity and an extra-large perfix plug mesh (device 3) was placed over the defect and secured with sutures and reapproximated to subcutaneous tissues.¿ on (b)(6) 2011: patient was diagnosed with recurrent right inguinal hernia thereby underwent open repair with implant of perfix plug (device 4).Per operative notes, ¿a large direct defect at the floor of the inguinal canal was reduced back into the preperitoneal space and another small indirect inguinal hernia with sac was noted and reduced.An extra-large perfix plug (device 4) was placed within the direct space also covering indirect spaces and secured with sutures.¿.

• 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: 24266561
• Report Number: 1213643-2026-00084
• Device Sequence Number: 18647232
• Product Code: FTL
• UDI-Device Identifier: 00801741031069
• UDI-Public: (01)00801741031069(17)120728(10)HUUF1391
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K091659
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2010
• Reporter Type: Manufacturer
• Report Source: Other,Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 01/22/2026

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 Expiration Date: 07/28/2012
• Device Catalogue Number: 0117321
• Device Lot Number: HUUF1391
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/17/2026
• Initial Report FDA Received Date: 02/05/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/15/2010
• 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: 58 YR
• Patient Sex: Male