MAUDE Adverse Event Report: Davol Inc., Sub. C.R. Bard, Inc. -1213643 Bard Flat Mesh; Surgical Mesh

Catalog Number	0112680
Medical Device Problem Code	Patient-Device Incompatibility (2682)
Health Effect - Clinical Codes	Adhesion(s) (1695); Obstruction/Occlusion (2422)
Date of Event	02/11/2017
Type of Reportable Event	Serious Injury
Event or Problem Description
Per information provided: (b)(6) 2006- patient was diagnosed with ventral incisional hernia, thereby underwent open repair with implant of composix kugel mesh (device 1).Per op notes, "hernia sac in abdominal region was identified and was dissected.A composix kugel mesh (device 1) was then placed o er the fascial defect and sutured." (b)(6) 2006 - patient was diagnosed with ventral incisional hernia thereby underwent open repair with explant of composix kugel mesh (device 1), implant of composix kugel mesh (device 2).Per op notes, "the previous midline scar tissue was excised.The hernia sac was identified and excised.The previously placed mesh (device 1) in the colostomy site was noted and was found bunched up and covered with adhesions sand the mesh (device 1) was removed.A large sized composix kugel mesh (device 2) was then placed in the abdominal region and was sutured." (b)(6) 2010 - patient was diagnosed with incisional hernia, left sided pain, thereby underwent open repair with implant of synthetic mesh.Per op notes, "the old scar was dissected.Hernia sac in left upper quadrant was identified and was dissected.A synthetic mesh was placed and sutured.In the right upper quadrant, the abdominal fascia was closed with sutures." (b)(6) 2011 - patient was diagnosed with abdominal wall pain, thereby underwent open repair with implant of bard flat mesh (device 3).Per op notes, "incision through previous scar, sutures closing the abdominal wall fascia was removed.A bard flat mesh (device 3) was then placed and sutured." (b)(6) 2017 - patient was diagnosed with small bowel obstruction, thereby underwent open repair with explant of composix kugel mesh (device 2), implant of synthetic mesh.Per op notes, "small bowel adhesions along the edge of the previously placed mesh (device 3) was taken down.Some adhesions along the abdominal wall was also identified.There were another adhesions noted in interior part of the mesh and was lysed.The composix kugel mesh (device 2) that was placed previously in colostomy sited was removed and a synthetic mesh was placed over the hernia site and tacked.".
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-dec-2007) is considered to be a best estimate.This emdr represents the bard flat mesh (device 3).An additional emdr and supplemental emdr were submitted to represent the composix kugel mesh (device 1 & 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.

• 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 ; +1(800)556-6756
• MDR Report Key: 50459844
• Report Number: 1213643-2026-01116
• Device Sequence Number: 18657668
• Product Code: FTL
• UDI-Device Identifier: 00801741016530
• UDI-Public: (01)00801741016530(17)121228(10)HURL0204
• Combination Product (Y/N): N
• Initial Reporter State: CO
• Initial Reporter Country: US
• PMA/510(K) Number: Preamendment
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2011
• Reporter Type: Manufacturer
• Report Source: Other,Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 08/21/2026

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: 12/28/2012
• Device Catalogue Number: 0112680
• Device Lot Number: HURL0204
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/18/2026
• Initial Report FDA Received Date: 08/26/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 12/15/2007
• 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 Sex: Female