5844-12

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 08 report with the FDA on 2011-12-07 for 5844-12 manufactured by Mizuho Osi.

Event Text Entries

[2456325] During the use of a pt care kit, the pt was found to have an allergic reaction where the kit touched the skin. The pt was given antihistamines and the allergic reaction subsided.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number2921578-2011-00035
MDR Report Key2401768
Report Source08
Date Received2011-12-07
Date of Report2011-12-05
Date Mfgr Received2011-11-30
Date Added to Maude2012-07-23
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag0
Health Professional0
Initial Report to FDA3
Report to FDA0
Event Location0
Manufacturer ContactKIRKE JAYNE
Manufacturer Street30031 AHERN AVE.
Manufacturer CityUNION CITY CA 945871234
Manufacturer CountryUS
Manufacturer Postal945871234
Manufacturer Phone5104768128
Single Use3
Remedial ActionRL
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand Name5844-12
Generic NameBEDDING, DISPOSABLE
Product CodeKME
Date Received2011-12-07
Model Number5844-12
Catalog Number5844-12
Lot NumberNA
Device AvailabilityN
Device AgeDA
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerMIZUHO OSI
Manufacturer Address30031 AHERN AVE. UNION CITY CA 94587 US 94587


Patients

Patient NumberTreatmentOutcomeDate
10 2011-12-07

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