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

Catalog Number	1202025
Medical Device Problem Code	Patient-Device Incompatibility (2682)
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	02/25/2024
Type of Reportable Event	Death
Additional Manufacturer Narrative
As reported, a patient in compromised health (recent history of enterocutaneous fistula and infection) was implanted with a phasix st mesh.Due to infection the mesh was subsequently explanted.The patient passed away due to complications of the infection (the exact date is not known and estimated between 29-feb - 11 mar).The surgeon has stated that the mesh was not responsible for this immune response.No medical records, autopsy report, or death certificate have been provided.Review of manufacturing records confirms product was manufactured to specification.To date, this is the only reported complaint for this manufacturing lot of (b)(4) units released for distribution in march 2023.Regarding infection, the instructions-for-use supplied with the device state, "if an infection develops, treat the infection aggressively.Consideration should be given regarding the need to remove the mesh.An unresolved infection may require removal of the mesh." and ¿the use of any synthetic mesh or patch in a contaminated or infected wound could lead to fistula formation and/or extrusion of the mesh and it is not recommended.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.H3 other text : not returned.
Event or Problem Description
As reported, the patient had a recent history of multiple enterocutaneous fistulas following formation of stoma and had subsequently been treated aggressively for infection.As reported, the surgeon believed that the underlying infection had cleared, and fistulas had closed and were looking to reinforce the patient's abdominal wall as it was the main concern as such a decision was made to use a phasix st mesh by onlay fashion.About 2 weeks post-implant, the mesh was explanted due to a massive systemic infection, during which it was noted that the mesh was floating in pus.As reported, the surgeon "did not believe that the mesh was at fault in this instance, but more likely that the infection wasn¿t completely resolved.Surgeon stated on reflection that mesh was not responsible for this immune response.Subsequently, it was reported that the patient had passed away due to complications of infection.

• Brand Name: PHASIX ST 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: 18955423
• Report Number: 1213643-2024-00096
• Device Sequence Number: 17278307
• Product Code: OWT
• UDI-Device Identifier: 00801741095368
• UDI-Public: (01)00801741095368
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K143380
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Device Explanted Year: 2024
• 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): 03/04/2024

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: 10/28/2025
• Device Catalogue Number: 1202025
• Device Lot Number: HUHN0582
• 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: Not provided
• Initial Report FDA Received Date: 03/21/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/23/2023
• 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: Death; Required Intervention
• Patient Sex: Unknown