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

Catalog Number	1190500
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Hernia (2240)
Date of Event	07/26/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Based on the information provided, no conclusion can be made as to the cause of the hernia recurrence.The patient had previously undergone a hemicolectomy.During the hernia repair surgery the previous procedure (hemicolectomy) was completed with a takedown of ileostomy with ileocolonic anastomosis.The cause of the patient's hernia recurrence is unknown at this time.To date there has been no surgical intervention.A review of the manufacturing records was performed and found that the lot was manufactured to specification.Recurrence is a known inherent risk of hernia repair surgery and is listed in the adverse reaction section of the instructions-for-use as a possible complication.Should additional information be provided, a supplemental emdr will be submitted.No sample to return.
Event or Problem Description
It was reported to davol that a patient who is part of a clinical study experienced a hernia recurrence.As reported per phasix clinical study dvl-he-011: on (b)(6) 2014 the subject patient underwent repair of a primary ventral hernia utilizing bard phasix mesh.An onlay placement with component separation, ramirez/open technique was performed.The length of the defect measured 24cm and measured 15cm in width.In addition to this procedure, lysis of adhesions and a takedown of ileostomy with ileocolonic anastomosis was performed.The method of perimeter fixation was absorbable monofilament suture with 20 fixation points.The fascia was re-approximated and the skin was fully closed.On (b)(6) 2017 the subject patient was diagnosed with a recurrent hernia.The adverse event has been assessed per the clinician as possibly related to the study device and possibly related to the index procedure.The adverse event has been assessed as mild in severity, not serious with an ongoing resolution date.No action has been taken.

• Brand Name: PHASIX FLAT 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: 9574819
• Report Number: 1213643-2020-00244
• Device Sequence Number: 3229480
• Product Code: OOD
• UDI-Device Identifier: 00801741077708
• UDI-Public: (01)00801741077708
• Combination Product (Y/N): N
• Initial Reporter State: IN
• Initial Reporter Country: US
• PMA/510(K) Number: K142818
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2014
• Reporter Type: Manufacturer
• Report Source: other,study
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 01/10/2020

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: 12/28/2014
• Device Catalogue Number: 1190500
• Device Lot Number: HUXCTP09
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/18/2019
• Initial Report FDA Received Date: 01/10/2020
• 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: 59 YR
• Patient Weight: 67