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

Catalog Number	0112740
Medical Device Problem Code	Patient-Device Incompatibility (2682)
Health Effect - Clinical Code	Hernia (2240)
Date of Event	11/11/2014
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-2011) is considered to be a best estimate.This emdr represents the bard mesh - dart (device 2).An additional supplemental emdr and emdr were submitted to represent the bard flat mesh (device 1 and 2).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) 2011- patient was diagnosed with right inguinal hernia, thereby underwent open repair with implant of bard flat mesh (device 1).Per op notes, ¿a large direct hernia was identified in the right inguinal region.A bard flat mesh (device 1) was placed on the posterior wall of inguinal canal and sutured¿.(b)(6) 2012- patient was diagnosed with recurrent right inguinal hernia, thereby underwent open repair with implant of bard flat mesh (device 2).Per op notes, ¿the old scar was dissected.Bard flat mesh (device 1) was found retracted towards the inguinal ligament which was then tacked and sutured.An indirect hernia was identified; a bard flat mesh (device 2) was placed and sutured¿.(b)(6)2013- patient was diagnosed with recurrent direct right inguinal hernia, thereby underwent open repair with implant of dart mesh (device 3).Per op notes, ¿a large, scarred hernia sac was identified inferior to the cord and was dissected.A dart mesh (device 3) was placed on the floor of the inguinal canal and sutured¿.(b)(6) 2014- patient was diagnosed with bilateral inguinal hernias, right recurrent, left direct, thereby underwent laproscopic repair with implant of 3dmax meshes (device 4 and 5).Per op notes, ¿a large direct hernia in the left inguinal region was identified and dissected.A right direct hernia was also identified and dissected.The dart mesh (device 3) was excised and there was no indirect hernia.3dmax meshes (device 4 and 5) was placed on left and right inguinal hernia defects respectively and was sutured¿.

• Brand Name: MESH - DART
• 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: 23788185
• Report Number: 1213643-2025-01195
• Device Sequence Number: 21450203
• Product Code: FTL
• UDI-Device Identifier: 00801741016585
• UDI-Public: (01)00801741016585(17)160628(10)HUVF0101
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K922916
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2013
• Device Explanted Year: 2014
• Reporter Type: Manufacturer
• Report Source: Other,Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 12/10/2025

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: 06/28/2016
• Device Catalogue Number: 0112740
• Device Lot Number: HUVF0101
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/20/2025
• Initial Report FDA Received Date: 12/12/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/15/2011
• 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: 41 YR
• Patient Sex: Male