EHR

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-04-04 for EHR manufactured by Unk.

Event Text Entries

[141310328] I discovered that in my ehr, my alpha-gal allergy is specifically listed as a 'non drug allergy. ' this is wrong. When i tried to contact my dr to get it changed, they said they 'did not see that in their system'. I of course, have no way to know if they were looking at the same thing i was. Bottom line though is that info is in the system somewhere, and it needs to be fixed. This could be a life threatening issue. Http://mycw39. Eclinicalweb. Com/region6/jsp/100mp/login_otp. Jsp.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report NumberMW5085625
MDR Report Key8487684
Date Received2019-04-04
Date of Report2019-03-29
Date of Event2019-03-25
Date Added to Maude2019-04-05
Event Key0
Report Source CodeVoluntary report
Manufacturer LinkN
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Reporter OccupationPATIENT
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Single Use3
Previous Use Code3
Event Type3
Type of Report0

Device Details

Brand NameEHR
Generic NameMEDICAL DEVICE DATA SYSTEM
Product CodeOUG
Date Received2019-04-04
Device AvailabilityY
Device Eval'ed by MfgrI
Device Sequence No1
Device Event Key0
ManufacturerUNK
Manufacturer AddressUNK UNK


Patients

Patient NumberTreatmentOutcomeDate
101. Required No Informationntervention 2019-04-04

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