NON27382Z

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional,user faci report with the FDA on 2019-01-09 for NON27382Z manufactured by Medline Industries Inc..

Event Text Entries

[132497832] 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.
Patient Sequence No: 1, Text Type: N, H10


[132497833] It was reported that the nurse developed allergic reaction to the surgical facemask and the nurse required treatment with steroids and epinephrine injection.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number1417592-2018-00142
MDR Report Key8230910
Report SourceHEALTH PROFESSIONAL,USER FACI
Date Received2019-01-09
Date of Report2019-01-09
Date of Event2018-12-11
Date Mfgr Received2018-12-13
Date Added to Maude2019-01-09
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Manufacturer ContactBERMON PUNZALAN
Manufacturer StreetTHREE LAKES DRIVE
Manufacturer CityNORTHFIELD IL 60093
Manufacturer CountryUS
Manufacturer Postal60093
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Generic NameMASK,FACE,GREEN,CHAMBER,TIES,LF
Product CodeFXX
Date Received2019-01-09
Catalog NumberNON27382Z
Lot NumberUNK
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerMEDLINE INDUSTRIES INC.
Manufacturer AddressTHREE LAKES DRIVE NORTHFIELD IL 60093 US 60093


Patients

Patient NumberTreatmentOutcomeDate
101. Required No Informationntervention 2019-01-09

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