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

Catalog Number	1190300
Medical Device Problem Code	Use of Device Problem (1670)
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	01/15/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
As reported, two (2) months post implant of a phasix mesh into an infected environment, the mesh was removed due to severe infection.A video was provided and shows a heavily contaminated mesh that had been explanted from the patient.Video review does not assist in root cause determination.Based on the event as reported the mesh was implanted into an infected environment and when the infection worsened the mesh was explanted.There is no indication in the information provided that a malfunction of the device caused the mesh to be explanted.A review of manufacturing and sterilization records was conducted and confirmed that the device was manufactured in accordance with specifications, with no anomalies identified during the process.To date, this is the only reported complaint for this manufacturing lot of 145 units released for distribution.Based on the information provided the mesh was explanted due to an infection that preexisted prior to mesh implant.The warning section of the instructions-for-use provided with the device states, "the use of any mesh or patch in a contaminated or infected wound can lead to fistula formation and/or extrusion of the mesh" and "if an infection develops, treat the infection aggressively.Consideration should be given regarding the need to remove the mesh.An unresolved infection may require the removal of the mesh." 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
As reported on (b)(6) 2026, the patient was implanted with a phasix mesh.As reported, the mesh was used in an "infected hernia case." reportedly, two (2) months post implantation the phasix mesh was removed due to severe infection.

• 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 ; 8005566756
• MDR Report Key: 25525225
• Report Number: 1213643-2026-00762
• Device Sequence Number: 21517633
• Product Code: OOD
• UDI-Device Identifier: 00801741077685
• UDI-Public: (01)00801741077685(11)250502(17)270428(10)HUKS0173
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• 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,Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 06/05/2026

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: 1190300
• Device Lot Number: HUKS0173
• 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: 06/03/2026
• Initial Report FDA Received Date: 06/16/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/02/2025
• 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: Required Intervention
• Patient Sex: Unknown