ACORN 180 T564 RH US

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a other report with the FDA on 2019-11-21 for ACORN 180 T564 RH US manufactured by Acorn Stairlift, Inc..

MAUDE Entry Details

Report Number3003124453-2019-00009
MDR Report Key9358487
Report SourceOTHER
Date Received2019-11-21
Date of Report2019-11-21
Date of Event2018-08-04
Date Mfgr Received2019-10-22
Device Manufacturer Date2016-07-01
Date Added to Maude2019-11-21
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Manufacturer ContactMS. DORIAN PEARSON-SHAVER
Manufacturer Street7001 LAKE ELLENOR DRIVE
Manufacturer CityORLANDO FL 32809
Manufacturer CountryUS
Manufacturer Postal32809
Manufacturer Phone4076500216
Manufacturer G1ACORN STAIRLIFTS, INC.
Manufacturer Street7001 LAKE ELLENOR DRIVE
Manufacturer CityORLANDO FL 32809
Manufacturer CountryUS
Manufacturer Postal Code32809
Single Use3
Remedial ActionOT
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameACORN 180 T564 RH US
Generic NamePOWER STAIRWAY CHAIR LIFT
Product CodePCD
Date Received2019-11-21
Returned To Mfg2019-11-15
OperatorLAY USER/PATIENT
Device AvailabilityR
Device Eval'ed by MfgrY
Device Sequence No1
Device Event Key0
ManufacturerACORN STAIRLIFT, INC.
Manufacturer Address7001 LAKE ELLENOR DRIVE ORLANDO FL 32809 US 32809


Patients

Patient NumberTreatmentOutcomeDate
101. Death 2019-11-21

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