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

Catalog Number	1202025
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	Hernia (2240)
Date of Event	12/20/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
As reported, the patient developed a hernia recurrence and a rupture through the center of the phasix st mesh was noted during re-repair procedure.Intraoperative images provided confirm hernia recurrence.Photos show the phasix st mesh to be well integrated as reported.Based on the time in the body the phasix st mesh has resorbed as would be expected per the ifu.The information provided is limited and it is unclear what may have caused or contributed to the patient¿s postoperative course.Hernia recurrence is a known inherent risk of hernia repair surgery and is a labeled side effect listed in the instructions-for-use, supplied with the device.No lot number has been provided; therefore, a review of the manufacturing records is not possible.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, the patient was implanted with a phasix st mesh on (b)(6) 2021 for the repair of a 2x4 cm hernia defect.In (b)(6) 2023, the patient experienced a hernia recurrence and revisited the surgeon on (b)(6) 2023.On (b)(6) 2023 the patient underwent repair, and the surgeon states the previously placed mesh had ¿ruptured through the center.¿ the phasix st mesh was not removed as it had ¿integrated into the tissue well.¿ the recurrence was repaired with the implant of a ventralight st mesh.

• 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: 18951316
• Report Number: 1213643-2024-00095
• Device Sequence Number: 20809871
• 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: 2021
• 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?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 1202025
• 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: 03/01/2024
• Initial Report FDA Received Date: 03/21/2024
• 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: Male
• Patient Weight: 100 KG