DRIVE MEDICAL ATC19-BL

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-05-11 for DRIVE MEDICAL ATC19-BL manufactured by Danyang Jumao Healthcare Equipment Co.,ltd.

Event Text Entries

[74948400] (b)(4) received notice about this claim from the dme provider, (b)(6), involving a transport chair, a product imported and distributed by (b)(4). The end user went to sit in the chair when the folding hinges allegedly broke causing the end user to fall. Emergency services were called to help the patient get up. No injuries was reported. (b)(4) is in the process of getting the product back to further the investigation. This report is based on the information that was provided by the provider.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number2438477-2017-00045
MDR Report Key6560675
Date Received2017-05-11
Date of Report2017-04-13
Date of Event2017-04-12
Date Facility Aware2017-04-13
Report Date2017-05-11
Date Reported to FDA2017-05-11
Date Reported to Mfgr2017-05-11
Date Added to Maude2017-05-11
Event Key0
Report Source CodeDistributor report
Manufacturer LinkN
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
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameDRIVE MEDICAL
Generic NameCHAIR, WITH CASTERS
Product CodeINM
Date Received2017-05-11
Model NumberATC19-BL
OperatorLAY USER/PATIENT
Device AvailabilityN
Device Age3 YR
Device Eval'ed by Mfgr*
Device Sequence No1
Device Event Key0
ManufacturerDANYANG JUMAO HEALTHCARE EQUIPMENT CO.,LTD
Manufacturer AddressNO.36 DANYAN ROAD DANYANG CITY, JIANGSU PROVINCE JIANGSU 212300 CH 212300


Patients

Patient NumberTreatmentOutcomeDate
101. Other 2017-05-11

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