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

Catalog Number	0112660
Medical Device Problem Code	Device Appears to Trigger Rejection (1524)
Health Effect - Clinical Codes	Adhesion(s) (1695); Hernia (2240); Obstruction/Occlusion (2422)
Date of Event	07/03/2009
Type of Reportable Event	Serious Injury
Event or Problem Description
Per information provided: on (b)(6) 2009 - patient was diagnosed with two incisional hernias thereby underwent open repair with implant of bard flat mesh (device 1 and device 2).Per op notes, ¿the midline fascial defect was approached first.An incision was made on the pervious scar.The hernia sac was identified and isolated from the fascia.A bard flat mesh (device 1) was placed on the defect and was secured with sutures.To repair the hernia in the kidney transplant scar (rlq), the previous scar was excised and dissected the subcutaneous tissue down to fascia.The hernia sac was identified and isolated from the fascia.A bard flat mesh (device 2) was placed on the defect and secured with sutures." on (b)(6) 2009 - patient was diagnosed with incarcerated incisional hernia and small bowel obstruction thereby underwent repair.Per op notes, "noted the previously placed bard flat mesh (device 2) in the rlq was intact with small bowel protruding through it.Adhesions were dissected free.A synthetic mesh was placed to the abdominal wall defect with tacks.The previously placed mesh (device 1) was left on top of the defect and was still in place.And another synthetic mesh was placed to the midline incision and secured with 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-nov-2008) is considered to be a best estimate.This emdr represents the bard flat mesh (device 2).An additional supplemental emdr was submitted to represent the bard flat 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.

• 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: 50083002
• Report Number: 1213643-2026-00978
• Device Sequence Number: 21395768
• Product Code: FTL
• UDI-Device Identifier: 00801741016516
• UDI-Public: (01)00801741016516(17)131128(10)HUSK1327
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K251557
• 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): 07/18/2026

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: 11/28/2013
• Device Catalogue Number: 0112660
• Device Lot Number: HUSK1327
• 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: 07/15/2026
• Initial Report FDA Received Date: 07/30/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/15/2008
• 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