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

Catalog Number	1190500
Medical Device Problem Code	Patient-Device Incompatibility (2682)
Health Effect - Clinical Code	Fever (1858)
Date of Event	08/06/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
As reported, on (b)(6) 2026 during a robotic ventral hernia repair procedure the patient was implanted with phasix flat mesh.As reported, the patient had a post-operative fever and the patient's wife called the surgeon multiple times reporting her concerns.There was no reported treatment provided by the surgeon.In follow up with the surgeon it is reported that, "the patient no longer has a fever and doing well.".
Additional Manufacturer Narrative
As reported, the patient developed a fever post implant of phasix mesh.As per the surgeon, "the patient no longer has a fever and doing well." there was no reported treatment provided by the surgeon.Based on the information available to date, no conclusions can be made as to the degree to which the implant may have caused or contributed to the patient's postoperative fever.Review of manufacturing records confirms the product was manufactured to specification.To date, this is the only reported complaint for this manufacturing lot of (b)(4) units.Note, the date of event ((b)(6) 2026) is considered to be the best estimate based on the date of awareness.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: Phasix 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: 50456685
• Report Number: 1213643-2026-01106
• Device Sequence Number: 9780016
• Product Code: OOD
• UDI-Device Identifier: 00801741077708
• UDI-Public: (01)00801741077708(11)250616(17)270528(10)HUKT0880
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• PMA/510(K) Number: K142818
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2026
• Reporter Type: Manufacturer
• Report Source: Other,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 08/11/2026

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 Catalogue Number: 1190500
• Device Lot Number: HUKT0880
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/06/2026
• Initial Report FDA Received Date: 08/26/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/16/2025
• 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: Other
• Patient Sex: Male