MEDICHOICE SURGICAL MASK PG4-2121

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-02-13 for MEDICHOICE SURGICAL MASK PG4-2121 manufactured by Owens & Minor Distribution, Inc..

Event Text Entries

[136043576] Several employees reported rashes on their face after using surgical mask. The masks were in place for 8 hours. Two employees developed rashes after the masks were taken off. The rash that developed was red bumps noted to bilateral cheeks with "burning" to face, then blisters the following day x 2 employees. Both employees were seen in clinic and advised to change mask types.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number8335376
MDR Report Key8335376
Date Received2019-02-13
Date of Report2019-01-25
Date of Event2018-12-07
Report Date2019-01-25
Date Reported to FDA2019-01-25
Date Reported to Mfgr2019-02-13
Date Added to Maude2019-02-13
Event Key0
Report Source CodeUser Facility report
Manufacturer LinkN
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Reporter OccupationRISK MANAGER
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameMEDICHOICE SURGICAL MASK
Generic NameMASK, SURGICAL
Product CodeFXX
Date Received2019-02-13
Model NumberPG4-2121
Catalog NumberPG4-2121
Device AvailabilityN
Device Age1 DA
Device Eval'ed by Mfgr*
Device Sequence No1
Device Event Key0
ManufacturerOWENS & MINOR DISTRIBUTION, INC.
Manufacturer Address9120 LOCKWOOD BLVD MECHANICSVILLE VA 23116 US 23116


Patients

Patient NumberTreatmentOutcomeDate
101. Other 2019-02-13

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