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	03/03/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Root cause is undetermined.Based on the information provided, no conclusion can be made as to the cause of the hernia recurrence.As reported this patient has a history of crohn's disease and had undergone multiply abdominal surgeries subsequently developing an 8cm x 18cm swiss cheese incisional hernia.No conclusions can be made however, given the patient's medical/surgical history it is possible that the patient's comorbidities may have contributed to the hernia recurrence.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.On (b)(6) 2015 the subject patient underwent an open repair of a first time recurrent midline incisional hernia using the phasix mesh.A retro-rectus placement with component separation ramirez technique was utilized.The length of the swiss cheese like defect measured 8 cm and the width measured 18 cm.Perimeter fixation was performed with absorbable monofilament suture.Eight (8) points of fixation were made.The wound and fascia were closed, the skin was fully closed.On (b)(6) 2017 the subject patient was diagnosed with a recurrent hernia (7 x 7 cm) in the same location.On (b)(6) 2017 the subject patient underwent additional surgery to repair the recurrent hernia.A primary repair was performed.This recurrent hernia has been assessed per the study clinician as possibly related to the device and definitely related to the index procedure.The clinician has assessed the recurrence as a serious adverse event of moderate severity.

• 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: 9571993
• Report Number: 1213643-2020-00194
• Device Sequence Number: 14062536
• 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: 2015
• Reporter Type: Manufacturer
• Report Source: other,study
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 01/09/2020

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: 04/28/2016
• Device Catalogue Number: 1190500
• Device Lot Number: HUYBTP05
• 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: 01/09/2020
• 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: 25 YR
• Patient Weight: 75