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

Catalog Number	0112730
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Codes	Scar Tissue (2060); Hernia (2240)
Date of Event	05/13/2016
Type of Reportable Event	Serious Injury
Event or Problem Description
Per information provided: (b)(6) 2012 ¿ patient was diagnosed with incarcerated ventral hernia and incarcerated umbilical hernia thereby underwent open repair with implant of mesh ¿ darts (device 1) and mesh ¿ darts (device 2).Per operative notes, ¿a transverse elliptical incision was made around the umbilicus.A large mesh ¿ darts (device 1) was placed and sutured.A vertical incision was made over the epigastric hernia and carried down to the defect and dissected.A mesh ¿ darts (device 2) was placed and sutured in place.¿ (b)(6) 2014 ¿ patient was diagnosed with recurrent incisional hernia to the right of the prior umbilical hernia repair thereby underwent open repair with ventralex st mesh (device 3).Per operative notes, ¿the scar tissue was noted.The defect was repaired with a ventralex st mesh (device 3) and sutured.¿ (b)(6) 2016 ¿ patient was diagnosed with recurrent incisional hernia at the umbilicus thereby underwent laparoscopic repair with removal of mesh ¿ darts (device 1) and ventralex st mesh (device 3).Per operative notes, ¿the recurrent hernia at the umbilicus with the previous mesh, turns out that the mesh did not remain anchored on the right abdominal wall, and was curl up in pointing inward with small bowel attached to it and small bowel extending up into the hernia sac.The meshes were removed (device 1 and device 3) as it was all balled up.The scar tissue was noted.The hernia sac was removed.A ventralight st mesh (device 4) was placed and tacked to the abdominal wall.¿.
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-feb-2012) is considered to be a best estimate.This mdr represents the mesh ¿ dart (device 1).An additional supplemental emdr was submitted to represent the ventralex st mesh (device 3).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.

• 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: 23729898
• Report Number: 1213643-2025-01171
• Device Sequence Number: 21263167
• Product Code: FTL
• UDI-Device Identifier: 00801741016578
• UDI-Public: (01)00801741016578(17)170228(10)HUWB0500
• Combination Product (Y/N): N
• Initial Reporter State: VI
• Initial Reporter Country: US
• PMA/510(K) Number: K922916
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2012
• Device Explanted Year: 2016
• Reporter Type: Manufacturer
• Report Source: Other,Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 12/03/2025

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: 02/28/2017
• Device Catalogue Number: 0112730
• Device Lot Number: HUWB0500
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/13/2025
• Initial Report FDA Received Date: 12/05/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/15/2012
• 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: Required Intervention
• Patient Age: 66 YR
• Patient Sex: Male