SCALE

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-04-20 for SCALE manufactured by Unk.

Event Text Entries

[73600270] I was donating plasma and there's a new electronic system. I was deferred weighing in at (b)(6) but they weighed me in the next room and i weighed (b)(6). I weighed myself previously that morning before going and i was (b)(6). This is the 2nd time this week i have been deferred. I have lost out on (b)(6) and i believe now i do not qualify for my bonus because of the inaccurate scale and the new system.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report NumberMW5069262
MDR Report Key6515633
Date Received2017-04-20
Date of Report2017-04-20
Date of Event2017-04-20
Date Added to Maude2017-04-24
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 NameSCALE
Generic NameSCALE, PATIENT
Product CodeFRW
Date Received2017-04-20
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device Eval'ed by MfgrI
Device Sequence No1
Device Event Key0
ManufacturerUNK


Patients

Patient NumberTreatmentOutcomeDate
101. Required No Informationntervention 2017-04-20

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.