MAUDE Adverse Event Report: MEDLINE INDUSTRIES INC.; MASK,FACE,GREEN,CHAMBER,TIES,LF

Catalog Number	NON27382Z
Health Effect - Clinical Code	Reaction (2414)
Date of Event	12/11/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
It was reported that after eight hours of wearing the chamber-style surgical face mask, upon taking the facemask off, the nurse noted "red, raised, hot skin on the right side of my face, as well as tightening in my throat".Per report, the nurse immediately went to the emergency department where she was given steroids and an epinephrine injection.The nurse reportedly has allergies to penicillin and clams.Due to the reported incident and need for medical intervention, this medwatch is being filed.Samples are not available to be returned for evaluation.A root cause could not be determined at this time.No additional information is available.If additional information becomes available, a supplemental medwatch will be filed.
Event or Problem Description
It was reported that the nurse developed allergic reaction to the surgical facemask and the nurse required treatment with steroids and epinephrine injection.

• Common Device Name: MASK,FACE,GREEN,CHAMBER,TIES,LF
• Manufacturer (Section D): MEDLINE INDUSTRIES INC.; three lakes drive; northfield IL 60093
• MDR Report Key: 8230910
• Report Number: 1417592-2018-00142
• Device Sequence Number: 1910374
• Product Code: FXX
• UDI-Device Identifier: 10080196713912
• UDI-Public: 10080196713912
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 01/09/2019

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 Catalogue Number: NON27382Z
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/13/2018
• Initial Report FDA Received Date: 01/09/2019
• 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: 40 YR
• Patient Weight: 95