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

Catalog Number	1200015
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Abdominal Pain (1685); Pain (1994); Hernia (2240)
Date of Event	07/16/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Based on the information provided we are unable to determine to what extent, if any the phasix st mesh may have caused or contributed to the patients hernia recurrence.Based on the available information, no conclusion can be made.Recurrence is a known inherent risk of hernia repair surgery.Regarding recurrence the warning section of the instructions-for-use state, "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.If additional information is provided, a supplemental emdr will be submitted.Note: the information provided by bard 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 bard.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 patient underwent a laparoscopic, intra-abdominal hernia repair and was implanted with a phasix st mesh.The phasix st is noted to have been positioned so that its edges extend beyond the margins of the defect by at least 5cm.On (b)(6) 2018 - the patient was reported to have had low quadrant abdominal pain.On (b)(6) 2018 - the patient presented for his 18 month follow up visit.A hernia recurrence was confirmed upon physical exam.This adverse event was assessed per the clinician as moderate in severity, possibly related to the study device and possibly related to the procedure.The adverse event is identified as not recovered / not resolved.No intervention has been taken at this time.

• 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: 7747252
• Report Number: 1213643-2018-02597
• Device Sequence Number: 1084393
• Product Code: OWT
• UDI-Device Identifier: 00801741095290
• UDI-Public: (01)00801741095290
• Combination Product (Y/N): N
• Initial Reporter State: CT
• 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: health professional,other,stu
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 08/03/2018

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: 07/28/2018
• Device Catalogue Number: 1200015
• Device Lot Number: HUAU0482
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/16/2018
• Initial Report FDA Received Date: 08/03/2018
• 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: 58 YR