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

Catalog Number	0112720
Medical Device Problem Code	Patient-Device Incompatibility (2682)
Health Effect - Clinical Codes	Adhesion(s) (1695); Hernia (2240)
Date of Event	11/19/2010
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.This mdr represents the bard flat mesh (device 2).An additional supplemental emdr was submitted to represent the composix kugel mesh (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) 2005 - patient was diagnosed with recurrent ventral hernia thereby underwent laparoscopic repair with implant of composix kugel (device 1).Per op notes, ¿omental adhesions were lysed.Two defects were noted in the upper abdomen lateral to prior mesh.Both defects were joined.A composix kugel (device 1) was placed into the abdomen covering both defects and secured using tacks.¿ (note: the prior mesh visualized during this procedure was unknown) (b)(6) 2009 - patient was diagnosed with recurrent incisional hernia thereby underwent open repair with excision of composix kugel (device 1) and implant of bard flat mesh (device 2).Per op notes, ¿a small hernia sac was noted contained peritoneal fat were dissected down at the level of fascia and excised.Adhesions were lysed.The old kugel type mesh (device 1) was underneath the hernia and had come loose, slipped from the tissues creating hernia.The mesh (device 1) was excised.The defect was noted and reduced.A bard flat mesh (device 2) was placed and secured with sutures.¿ (b)(6) 2010 - patient was diagnosed with recurrent ventral hernia thereby underwent open repair with implant of visilex mesh (device 3).Per op notes, ¿recurrent ventral hernia was noted in the upper aspect of old incision.The hernia sac was opened and contained peritoneal fat were reduced.The hernia sac was excised.The hernia defect was at the edge of prior mesh (device 2).Adhesions to mesh (device 2) were lysed.A visilex mesh (device 3) was placed and sutured.¿.

• 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: 23941383
• Report Number: 1213643-2025-01296
• Device Sequence Number: 7946427
• Product Code: FTL
• UDI-Device Identifier: 00801741016561
• UDI-Public: (01)00801741016561(10)43EQD101
• 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: 2009
• Reporter Type: Manufacturer
• Report Source: Other,Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 12/31/2025

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 Catalogue Number: 0112720
• Device Lot Number: 43EQD101
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/10/2025
• Initial Report FDA Received Date: 01/02/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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: 45 YR
• Patient Sex: Male