644

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2015-10-16 for 644 manufactured by Seca Corp..

Event Text Entries

[28512220]
Patient Sequence No: 1, Text Type: N, H10


[28512221] The scale is just overly sensitive as far as being on a balanced floor. You can level it but if it gets moved just a hair it throws it off. It is to the point where the hospital refuses to even use the scale any more.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number5155733
MDR Report Key5155733
Date Received2015-10-16
Date of Report2015-09-29
Date of Event2015-09-29
Report Date2015-09-29
Date Reported to FDA2015-09-29
Date Reported to Mfgr2015-09-29
Date Added to Maude2015-10-16
Event Key0
Report Source CodeUser Facility report
Manufacturer LinkN
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Reporter OccupationBIOMEDICAL ENGINEER
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Generic NameSCALE
Product CodeFRW
Date Received2015-10-16
Model Number644
OperatorNURSE
Device AvailabilityY
Device Age1 YR
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerSECA CORP.
Manufacturer Address13601 BENSON AVE CHINO, CA 91710 US 91710


Patients

Patient NumberTreatmentOutcomeDate
10 2015-10-16

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