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	Adhesion(s) (1695); Scar Tissue (2060); Hernia (2240)
Date of Event	03/01/2011
Type of Reportable Event	Serious Injury
Event or Problem Description
Per information provided: (b)(6) 2009 - patient was diagnosed with ventral and umbilical hernia thereby underwent open repair with implant of bard pre-shaped mesh (device 1) and bard ¿ dart mesh (device 2).Per op notes, ¿adhesions were lysed.The hernia defect was noted, and the omentum was stuck in the defect were reduced.A portion omentum was excised.A bard pre-shaped mesh (device 1) was placed and sutured to fascia.The umbilical defect was noted and reduced.A mesh - dart (device 2) was placed and sutured.¿ (b)(6) 2011 - patient was diagnosed with recurrent ventral umbilical hernia thereby underwent open repair with excision of bard ¿ dart (device 2) and implant of ventralex mesh (device 3).Per op notes, ¿entire scar tissues of previous surgery were excised.The prior plug (device 2) had come loose and excised.Many adhesions of small bowel were lysed.The bowel and omentum were reduced from the hernia sac.A portion of incarcerated omentum stuck in the sac was excised.A ventralex mesh (device 3) was placed in the defect and secured using sutures.¿ (b)(6) 2012 - patient was diagnosed with recurrent incarcerated ventral hernia and abdominal pain thereby underwent open repair with excision of bard pre-shaped mesh (device 1), ventralex mesh (device 3) and implant of sepramesh ip (device 4).Per op notes, ¿previous scar from xiphoidal to umbilicus was excised.The previously placed 2 meshes (device 1 and 3) had come loose and excised.Dense adhesions of bowel and omentum were lysed.The internal hernia was noted with incarcerated omentum.A portion of omentum was excised.A sepramesh ip (device 4) was placed and secured using sutures.¿.
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-2009) is considered to be a best estimate.This mdr represents the dart mesh (device 2).Additional supplemental emdr's were submitted to represent the bard pre-shaped mesh (device 1) and ventralex 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: 24313618
• Report Number: 1213643-2026-00106
• Device Sequence Number: 14871816
• Product Code: FTL
• UDI-Device Identifier: 00801741016578
• UDI-Public: (01)00801741016578(17)140428(10)HUTC1917
• Combination Product (Y/N): N
• Initial Reporter State: RI
• Initial Reporter Country: US
• PMA/510(K) Number: K922916
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2009
• Device Explanted Year: 2011
• Reporter Type: Manufacturer
• Report Source: Other,Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 01/27/2026

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: 04/28/2014
• Device Catalogue Number: 0112730
• Device Lot Number: HUTC1917
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/21/2026
• Initial Report FDA Received Date: 02/11/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/15/2009
• 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: 38 YR
• Patient Sex: Male