MEDICAL DEVICE DATA SYSTEM

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-02-06 for MEDICAL DEVICE DATA SYSTEM manufactured by Cerner Corporation.

Event Text Entries

[136261846] A patient? S medication history stated he was on saphris black cherry tablets. When interviewing patient, patient stated this was not one of his medications and had never taken this before. Upon further interviewing of the patient, the patient stated that he takes black cherry tablets at home as an herbal supplement. In researching this issue it was discovered that an rn had entered the saphris black cherry product into the medication history on a previous admission. This occurred when typing in? Black cherry? , the saphris black cherry tablets comes up as a product option to be entered into the medication history, but there was no option for a supplement of black cherry tablets to be selected. The emr that is being used is (b)(4) and the drug information vendor is (b)(4). Having the flavoring added to the name in a database can increase risk of selecting the wrong product as the flavor is not part of the official name of the medication. Would recommend drug information vendors change the name of saphris to be just? Saphris? Alone without the flavoring name. Of note, when entering the generic name asenapine this does not contain any wording relating to the flavoring of black cherry. Medication was not used by patient. Nurse made the initial error. When and how was the error discovered? In researching this issue it was discovered that an rn had entered the saphris black cherry product into the medication history on a previous admission. This occurred when typing in? Black cherry? , the saphris black cherry tablets comes up as a product option to be entered into the medication history, but there was no option for supplement of black cherry tablets to be selected. Access number: (b)(4). Patient counseling provided: unknown. (b)(6).
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report NumberMW5083824
MDR Report Key8315869
Date Received2019-02-06
Date of Report2019-02-06
Date Added to Maude2019-02-07
Event Key0
Report Source CodeVoluntary report
Manufacturer LinkN
Number of Patients in Event0
Adverse Event Flag0
Product Problem Flag0
Reprocessed and Reused Flag3
Reporter OccupationUNKNOWN
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Single Use3
Previous Use Code3
Event Type3
Type of Report0

Device Sequence Number: 0

Brand NameMEDICAL DEVICE DATA SYSTEM
Generic NameMEDICAL DEVICE DATA SYSTEM
Product CodeOUG
Date Received2019-02-06
Device Availability*
Device Eval'ed by MfgrI
Device Sequence No0
Device Event Key0
ManufacturerCERNER CORPORATION
Manufacturer AddressKANSAS CITY MO 64117 64117

Device Sequence Number: 1

Brand NameMEDICAL DEVICE DATA SYSTEM
Generic NameMEDICAL DEVICE DATA SYSTEM
Product CodeOUG
Date Received2019-02-06
Device Availability*
Device Eval'ed by MfgrI
Device Sequence No1
Device Event Key0
ManufacturerUNKNOWN


Patients

Patient NumberTreatmentOutcomeDate
10 2019-02-06

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