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

Catalog Number	0115311
Medical Device Problem Code	Patient-Device Incompatibility (2682)
Health Effect - Clinical Codes	Nerve Damage (1979); Pain (1994)
Date of Event	01/13/2015
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-oct-2012) is considered to be a best estimate.This emdr represents the bd 3dmax (device 2).An additional supplemental emdr was submitted to represent the bd 3dmax (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 sports inguinal hernia thereby underwent robotic-assisted laparoscopic repair with implant of 3dmax mesh (device 1 and 2).Per op notes, ¿a small indirect bilateral inguinal hernia was noted.Initially, in the right inguinal region, the defect was dissected and repaired using a 3dmax mesh (device 1), which was then sutured.Subsequently, in the left inguinal region, the defect was dissected, and a 3dmax mesh (device 2) was placed and sutured¿.(b)(6) 2014- patient was diagnosed with recurrent right groin pain, thereby underwent open repair.Per op notes, ¿the ilioinguinal nerve in right inguinal region was identified, isolated and passed off¿.(b)(6) 2015- patient was diagnosed with recurrent left groin pain, thereby underwent open repair.Per op notes, ¿the ilioinguinal nerve in left inguinal region was identified, isolated and passed off¿.(b)(6) 2019- patient was diagnosed with recurrent direct bilateral inguinal hernias, thereby underwent open repair with implant of bard flat mesh (device 3 and 4).Per op notes, ¿initially in the right inguinal region, a direct inguinal hernia defect was identified along the medial to inferior epigastric vessels which was repaired with bard flat mesh (device 3) and sutured.Subsequently, in the left inguinal region, the direct inguinal hernia defect was identified.It was repaired with bard flat mesh (device 4) and sutured¿.

• 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: 23438373
• Report Number: 1213643-2025-01047
• Device Sequence Number: 8552197
• Product Code: FTL
• UDI-Device Identifier: 00801741030734
• UDI-Public: (01)00801741030734(17)171028(10)HUWJ1163
• 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
• Reporter Type: Manufacturer
• Report Source: Other,Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 10/30/2025

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: 10/28/2017
• Device Catalogue Number: 0115311
• Device Lot Number: HUWJ1163
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/09/2025
• Initial Report FDA Received Date: 10/31/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/15/2012
• 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: Disability; Required Intervention
• Patient Age: 25 YR
• Patient Sex: Male