CARDINAL HEALTH 11440-900

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2020-03-27 for CARDINAL HEALTH 11440-900 manufactured by Cardinal Health 200, Llc.

Event Text Entries

[185223592] Hot pack (cardinal health) was activated and was cold like an ice pack, instead of warm.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number9888149
MDR Report Key9888149
Date Received2020-03-27
Date of Report2020-02-28
Date of Event2020-02-24
Report Date2020-02-28
Date Reported to FDA2020-02-28
Date Reported to Mfgr2020-03-27
Date Added to Maude2020-03-27
Event Key0
Report Source CodeUser Facility report
Manufacturer LinkN
Number of Patients in Event0
Adverse Event Flag0
Product Problem Flag3
Reprocessed and Reused Flag3
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameCARDINAL HEALTH
Generic NamePACK, HOT OR COLD, DISPOSABLE
Product CodeIMD
Date Received2020-03-27
Catalog Number11440-900
Device Availability*
Device Eval'ed by Mfgr*
Device Sequence No1
Device Event Key0
ManufacturerCARDINAL HEALTH 200, LLC
Manufacturer Address3651 BIRCHWOOD DRIVE WAUKEGAN IL 60085 US 60085


Patients

Patient NumberTreatmentOutcomeDate
10 2020-03-27

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