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

Catalog Number	0115321
Medical Device Problem Code	Patient-Device Incompatibility (2682)
Health Effect - Clinical Code	Pain (1994)
Date of Event	10/19/2017
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-mar-2010) is considered to be a best estimate.This mdr represents the 3dmax mesh (device 2).An additional supplemental emdr was submitted to represent the 3dmax 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 hernias thereby underwent laparoscopic repair with implant of 3dmax (device 1 and 2).Per op notes, ¿on the left side, a direct hernia defect was noted and reduced from cord structures.A 3dmax (device 1 - left) was placed and sutured.On the right side, a direct hernia defect was noted and reduced from cord.A 3dmax (device 2 - right) placed and sutured.¿ on (b)(6) 2017 - patient was diagnosed with bilateral inguinodynia thereby underwent robotic assisted repair with removal of 3dmax (device 1 and 2).Per op notes, ¿both the meshes (device 1 and 2) was easily identified and cleared off from the attachments.Prior meshes (device 1 and 2) were excised entirely.¿ on (b)(6) 2018 - patient was diagnosed with recurrent right inguinal hernia thereby underwent open repair with implant of perfix plug light (device 3).Per op notes, ¿the hernia sac was identified and freed from the cord structures.A perfix plug light (device 3) was placed and secured using sutures to pubic tubercle, conjoined tendon and shelving edge and covered direct and indirect spaces.¿.

• Brand Name: 3DMAX
• 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: 24456020
• Report Number: 1213643-2026-00229
• Device Sequence Number: 18475633
• Product Code: FTL
• UDI-Device Identifier: 00801741030765
• UDI-Public: (01)00801741030765(17)150428(10)HUUC0676
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K081010
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2010
• Device Explanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: Other,Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 02/16/2026

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: 04/28/2015
• Device Catalogue Number: 0115321
• Device Lot Number: HUUC0676
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/05/2026
• Initial Report FDA Received Date: 02/26/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/15/2010
• 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: 67 YR
• Patient Sex: Male