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

Catalog Number	1200015
Medical Device Problem Code	Patient-Device Incompatibility (2682)
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	10/18/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
As reported, during a ventral hernia repair procedure on (b)(6) 2024 the patient was implanted with a phasix st mesh.Reportedly on (b)(6) 2024 the patient was diagnosed with a post operative infection ¿where the mesh also got infected¿ and is undergoing antibiotics treatment.It is reported that there is a plan to explant the mesh, however a date was not provided.
Additional Manufacturer Narrative
As reported, post implant of phasix st mesh the patient developed a post operative infection and is undergoing antibiotic treatment.Based on the information provided, no conclusions can be made as to the degree to which the implant may have caused or contributed to the postoperative complication.Review of manufacturing records was performed and found the device was manufactured to specification.To date, this is the only reported complaint for this lot of (b)(4) units.Post operative infection is a known inherent risk of the surgery/use of the device and is included as a possible complication in the adverse reaction section of the instructions for use, supplied with the device.The warnings section states "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." 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 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: 20672579
• Report Number: 1213643-2024-00540
• Device Sequence Number: 15275120
• Product Code: OWT
• UDI-Device Identifier: 00801741095290
• UDI-Public: (01)00801741095290(11)231205(17)261128(10)HUHZ0310
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• PMA/510(K) Number: K143380
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted 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): 10/24/2024

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 Catalogue Number: 1200015
• Device Lot Number: HUHZ0310
• 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: 10/21/2024
• Initial Report FDA Received Date: 11/13/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 12/05/2023
• 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: Required Intervention
• Patient Sex: Female