SHOECOVER/ANTISKID/FLUIDREST/UNI 4872A

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,07 report with the FDA on 2005-05-11 for SHOECOVER/ANTISKID/FLUIDREST/UNI 4872A manufactured by Cardinal Health.

Event Text Entries

[396536] While wearing one of co's shoe covers housekeeping staff member slipped and fell while mopping, resulting in a humorous fracture.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number1423507-2005-00066
MDR Report Key601486
Report Source05,07
Date Received2005-05-11
Date of Report2005-05-11
Date of Event2005-03-25
Date Mfgr Received2005-04-06
Date Added to Maude2005-05-13
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 Location0
Manufacturer ContactMICHELE DONATICH
Manufacturer Street1430 WAUKEGAN ROAD BLDG KB
Manufacturer CityMCGAW PARK IL 60085
Manufacturer CountryUS
Manufacturer Postal60085
Manufacturer Phone8475786412
Manufacturer G1*
Manufacturer Street*
Manufacturer CityEL PASO
Manufacturer Country*
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameSHOECOVER/ANTISKID/FLUIDREST/UNI
Generic NameSHOECOVER/ANTISKID/FLUIDREST/UNI
Product CodeFXP
Date Received2005-05-11
Model Number4872A
Catalog Number4872A
Lot NumberUNK
ID Number*
OperatorOTHER
Device AvailabilityN
Device Eval'ed by MfgrR
Implant FlagN
Date Removed*
Device Sequence No1
Device Event Key591307
ManufacturerCARDINAL HEALTH
Manufacturer Address* MCGAW PARK IL * US
Baseline Brand NameSHOECOVER/ANTISKID/FLUIDREST/UNI
Baseline Generic NameSHOECOVER/ANTISKID/FLUIDREST/UNI
Baseline Model No4872A
Baseline Catalog No4872A
Baseline ID*


Patients

Patient NumberTreatmentOutcomeDate
101. Other 2005-05-11

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