QUICKIE PULSE 5 POWERCHAIR PLS5A-114217

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2020-01-15 for QUICKIE PULSE 5 POWERCHAIR PLS5A-114217 manufactured by Sunrise Medical (us) Llc.

Event Text Entries

[175730241] Due to wheelchair footplates fourth failure, fell to floor transferring. Four months without working footplates. (b)(6) came due to fall. Fda safety report id # (b)(4).
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report NumberMW5092274
MDR Report Key9595972
Date Received2020-01-15
Date of Report2020-01-13
Date of Event2019-12-29
Date Added to Maude2020-01-16
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 Report3

Device Details

Brand NameQUICKIE PULSE 5 POWERCHAIR
Generic NameWHEELCHAIR, POWERED
Product CodeITI
Date Received2020-01-15
Model NumberPLS5A-114217
OperatorLAY USER/PATIENT
Device AvailabilityY
Device Eval'ed by MfgrI
Device Sequence No1
Device Event Key0
ManufacturerSUNRISE MEDICAL (US) LLC


Patients

Patient NumberTreatmentOutcomeDate
10 2020-01-15

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