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

Catalog Number	1190500
Medical Device Problem Code	Patient Device Interaction Problem (4001)
Health Effect - Clinical Codes	Unspecified Infection (1930); Necrosis (1971); Impaired Healing (2378)
Date of Event	07/21/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Based on the information provided the phasix mesh was implanted into a patient with poor health who later developed an infection, wound healing issues, and skin necrosis.As reported the surgeon believes the necrosis is due to the patient's continued smoking and poor vascularization of the subcutaneous tissue.Regarding the patient's postoperative course a definitive conclusion cannot be made as to the cause of the patient's infection.However, the reported comorbidities (obesity, narcotic addition and tobacco use) would put the patient at high risk for infection, wound healing issues and necrosis and may have contributed to the outcome.Postoperative infection is a known inherent risk of surgery and is identified in adverse reaction section of the instructions-for-use as a possible complication.Should additional information be provided, a supplemental emdr will be submitted.Remains implanted.
Event or Problem Description
As reported on (b)(6) 2019 a patient that had multiple defects and questionable tissue (posterior sheath) underwent a retro rectus repair with pst and on-lay with bard phasix flat mesh.Three weeks postoperatively the patient developed a wound infection for which a wound vac was placed, also noted was exposed mesh.Approximately two weeks later the patient underwent washout and removal of dead subcutaneous tissue.It was noted that "the mesh was at least 90% incorporated and the surgeon was more than pleased and rather impressed." as of (b)(6) 2019 the surgeon reports "the patient¿s white blood cell count had gone back down to normal from antibiotics and washouts and the phasix mesh is more incorporated than i had ever hoped." as reported the patient is obese with a high bmi, is addicted to narcotics, and is a chronic smoker and as reported the surgeon "believed the tissue was dying due to the patient¿s continued smoking and poor vascularization to the subcutaneous tissue." his plan following is to keep an eye on the remaining tissue staying healthy, then skin graft and close the wound later on.

• Brand Name: PHASIX 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: 9005600
• Report Number: 1213643-2019-08666
• Device Sequence Number: 14066242
• Product Code: OOD
• UDI-Device Identifier: 00801741077708
• UDI-Public: (01)00801741077708
• Combination Product (Y/N): N
• Initial Reporter State: CO
• Initial Reporter Country: US
• PMA/510(K) Number: K142818
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 09/12/2019

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: 02/28/2021
• Device Catalogue Number: 1190500
• Device Lot Number: HUDN1464
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/27/2019
• Initial Report FDA Received Date: 09/12/2019
• 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