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

Catalog Number	0115320
Medical Device Problem Code	Patient-Device Incompatibility (2682)
Health Effect - Clinical Codes	Adhesion(s) (1695); Unspecified Infection (1930); Hernia (2240)
Date of Event	07/10/2015
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-may-2013) 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: (b)(6) 2013 ¿ patient was diagnosed with bilateral inguinal hernia thereby underwent laparoscopic repair with the implant of 3dmax mesh (device #1 ¿ left, device #2 ¿ right).Per op notes, ¿on left, inguinal hernia was taken down and a medium 3dmax mesh (device #1) was placed and secured to the cooper ligament and epigastric vessels.On right, a 3dmax mesh (device #2) was placed as a similar fashion of left and tacked.¿ (b)(6) 2013 -patient had chronic groin pain thereby underwent open repair with the removal of tacks.Per op notes, ¿on the right side, the tacks were unscrewed and removed.On left, thickened mesh (device #1) was noted.¿ (b)(6) 2014 ¿ patient was diagnosed with bilateral recurrent inguinal hernia and inguinodynia thereby underwent open repair with the partial removal of mesh (device #1, #2).Per op notes, ¿on right, laparoscopic mesh (device #2) in the preperitoneal space linear segment was removed and shouldice repair was done using sutures.Exact same procedure was done on left side and mesh (device #1) was removed.Then, the abdominal wall infection was noted.¿ (b)(6) 2015 ¿ patient was diagnosed with bilateral inguinodynia, bilateral nerve entrapment thereby underwent laparoscopic repair with removal of mesh (device #1, #2).Per op notes, ¿on both sides, lateral femoral cutaneous, femoral branch and genital branch were lysed and freed up.A small of mesh (device #1, #2) was densely adherent and ingrown in sac was left and major part of mesh (device #1, #2) were excised completely.¿.

• 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: 22662995
• Report Number: 1213643-2025-00690
• Device Sequence Number: 3702320
• Product Code: FTL
• UDI-Device Identifier: 00801741030758
• UDI-Public: (01)00801741030758(17)180528(10)HUXE0471
• 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: 2013
• Device Explanted Year: 2015
• Reporter Type: Manufacturer
• Report Source: Other,Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 07/23/2025

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 Expiration Date: 05/28/2018
• Device Catalogue Number: 0115320
• Device Lot Number: HUXE0471
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/09/2025
• Initial Report FDA Received Date: 07/30/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/15/2013
• 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: 23 YR
• Patient Sex: Male