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

Catalog Number	1200015
Medical Device Problem Code	Patient Device Interaction Problem (4001)
Health Effect - Clinical Code	Hernia (2240)
Date of Event	09/09/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Based on the available information, the cause of the patient's hernia recurrence cannot be determined.As reported currently no actions are required to treat the recurrent hernia.Recurrence is a known inherent risk of hernia repair surgery.Regarding hernia recurrence the warning section of the instructions-for-use states, "to prevent recurrences when repairing hernias, phasix st mesh must be large enough to provide sufficient overlap beyond the margins of the repair/primary closure.Careful attention to mesh fixation placement and spacing will help prevent excessive tension or gap formation between the mesh and fascial tissue.A review of the manufacturing records was performed and found that the lot was manufactured to specification.To date this is the only reported complaint for this manufacturing lot of (b)(4) units released for distribution in june, 2017.If additional information is provided, a supplemental emdr will be submitted.Remains implanted.
Event or Problem Description
It was reported to davol that a patient who is part of a clinical study experienced a hernia recurrence.On (b)(6) 2017 the subject patient underwent a laparoscopic repair of an umbilical hernia.Both suture and mechanical fixation were used to fixate the mesh.An intra-abdominal surgical technique was used.The hernia measured 5cm in length and 4cm in width.The phasix st mesh was not trimmed and was positioned so that its edges extended beyond the margins of the defect by at least 5cm.On (b)(6) 2019 the subject patient was diagnosed with a hernia recurrence.This hernia has been assessed per the clinician as mild in severity with no action taken at this time.The ae has been assessed as possibly related to the study device and not related to the index procedure.

• Brand Name: PHASIX ST MESH
• Common Device Name: SURGICAL MESH
• Manufacturer (Section D): DAVOL INC., SUB. C.R. BARD, INC.; 100 crossings blvd.; warwick RI 02886
• MDR Report Key: 9260913
• Report Number: 1213643-2019-10434
• Device Sequence Number: 2055242
• Product Code: OWT
• UDI-Device Identifier: 00801741095290
• UDI-Public: (01)00801741095290
• Combination Product (Y/N): N
• Initial Reporter State: NE
• Initial Reporter Country: US
• PMA/510(K) Number: K143380
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: other,study
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 10/31/2019

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: 05/28/2019
• Device Catalogue Number: 1200015
• Device Lot Number: HUBR1693
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/17/2019
• Initial Report FDA Received Date: 10/31/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 48 YR