CVS310410W

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a consumer report with the FDA on 2019-02-26 for CVS310410W manufactured by Medline Industries Inc..

Event Text Entries

[137168904] It was reported that end-user required treatment with steroids for allergic reaction to face mask. Per report, the end-user developed redness to bilateral cheeks and to area under the nose. Reportedly, the end-user wore the facemasks for five days, approximately 80% of the time. The end-user's symptoms reportedly resolved after two to three weeks. Of note, the end-user stated that she is "very sensitive" and added, "i also took oregano oil maybe that could have caused this (allergic reaction) too. " due to the reported incident and required medical intervention, this medwatch is being filed. Samples are not available to be returned for evaluation. A root cause could not be identified 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


[137168965] It was reported that end-user required treatment with steroids for allergic reaction to face mask.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number1417592-2019-00025
MDR Report Key8370385
Report SourceCONSUMER
Date Received2019-02-26
Date of Report2019-02-26
Date of Event2018-11-01
Date Mfgr Received2019-01-31
Date Added to Maude2019-02-26
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 NameFACE MASK,PROCEDURAL , EARLOOPS, BLUE,LF
Product CodeFXX
Date Received2019-02-26
Catalog NumberCVS310410W
Lot Number85817118311
OperatorLAY USER/PATIENT
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 2019-02-26

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