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 (15-feb-2024) is considered to be a best estimate as based on the information available.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, during an open incisional 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: 18846418
• Report Number: 1213643-2024-00072
• Device Sequence Number: 12850063
• 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