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

Catalog Number	1191020
Medical Device Problem Code	Patient-Device Incompatibility (2682)
Health Effect - Clinical Code	Seroma (2069)
Date of Event	02/15/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
As reported, the patient developed a seroma post implant of a phasix mesh.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 seroma.Seroma formation is a known inherent risk of surgery and is listed in the adverse reactions section of the instructions for use, supplied with the device as a possible complication.No lot number has been provided; therefore, a review of the manufacturing records is not possible.Note, the date of event ((b)(6) 2024) is considered to be a best estimate as based on the information available.
Event or Problem Description
As reported, during an open inguinal hernia repair the patient was implanted with a phasix mesh.Post implant the surgeon advised that a mild seroma was observed over a period of 12-15 months.It was reported that the mesh remains implanted, no medical/surgical intervention needed, and the patient is reported to be in good condition.

• 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: 18846424
• Report Number: 1213643-2024-00073
• Device Sequence Number: 20772798
• Product Code: OOD
• UDI-Device Identifier: 00801741107573
• UDI-Public: (01)00801741107573
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K161424
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• 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): 02/22/2024

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: 1191020
• 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: 02/15/2024
• Initial Report FDA Received Date: 03/06/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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