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

Catalog Number	0112670
Medical Device Problem Code	Patient-Device Incompatibility (2682)
Health Effect - Clinical Codes	Hematoma (1884); Hernia (2240); Swelling/ Edema (4577)
Date of Event	02/04/2013
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-2009) is considered to be a best estimate.This emdr represents the bard flat mesh (device 1).Additional emdr was submitted to represent the kugel patch (device 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 additional information provided: (b)(6) 2010 ¿ patient was diagnosed with ventral hernia thereby underwent open repair with the implant of bard flat mesh (device 1).Per op notes, ¿a small defect was identified in midline above umbilicus.Then, a bard flat mesh (device 1) was laid over the top and tacked using sutures.¿ (b)(6) 2012 ¿ patient was diagnosed with recurrent ventral hernia thereby underwent open repair with the implant of kugel patch (device 2).Per op notes, ¿there were noted to be two areas where the fascia had weakened in the midline.The small oval kugel patch (device 2) was laid overlying the fascia and tacked using sutures circumferentially.¿ (b)(6) 2013 ¿ patient was diagnosed with chronic pain and swelling from abdominal wall mesh thereby underwent open repair with the removal of meshes (device 1, 2).Per op notes, ¿the mesh (device 1, 2) was completely excised.There were several small defects of the fascia and anterior rectus sheath, which were identified and were closed with sutures.".

• Brand Name: BARD FLAT MESH
• 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: 23727471
• Report Number: 1213643-2025-01167
• Device Sequence Number: 13316038
• Product Code: FTL
• UDI-Device Identifier: 00801741016523
• UDI-Public: (01)00801741016523(17)141028(10)HUTJ0738
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: PREAMENDMENT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2010
• Device Explanted Year: 2013
• 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: 10/28/2014
• Device Catalogue Number: 0112670
• Device Lot Number: HUTJ0738
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/12/2025
• Initial Report FDA Received Date: 12/05/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/15/2009
• 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: 64 YR
• Patient Sex: Male
• Patient Weight: 85 KG