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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: NINGBO SHENYU MEDICAL EQUIPMENT DRIVE; ROLLAOTR
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NINGBO SHENYU MEDICAL EQUIPMENT DRIVE; ROLLAOTR Back to Search Results
Model Number R728BL
Device Problem Device Operates Differently Than Expected (2913)
Patient Problems Bruise/Contusion (1754); Fall (1848); Swelling (2091); Injury (2348)
Event Date 04/16/2018
Event Type  Injury  
Event Description
(b)(4) is the initial importer of the device which is a rollator.The end-user was using the rollator at home.He rested his stump on the seat while using the device.During use the back right leg snapped off.He fell and hit his head.His stump jammed into the flooring.He sustained cuts, bruises, and swelling.There is potential injury to the stump.Our post market surveillance analyst is awaiting return of the item for root cause analysis.The end-user is reluctant to return the device upon advice of his attorney,.
 
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Brand Name
DRIVE
Type of Device
ROLLAOTR
Manufacturer (Section D)
NINGBO SHENYU MEDICAL EQUIPMENT
west of tanjialing road
yuyao
zhejiang, 31540 8
CH  315408
MDR Report Key7520258
MDR Text Key108487299
Report Number2438477-2018-00025
Device Sequence Number1
Product Code ITJ
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Distributor
Reporter Occupation Other
Type of Report Initial
Report Date 05/16/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/16/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Lay User/Patient
Device Model NumberR728BL
Was Device Available for Evaluation? No
Was the Report Sent to FDA? Yes
Date Report Sent to FDA05/16/2018
Distributor Facility Aware Date04/18/2018
Device Age48 MO
Event Location Home
Date Report to Manufacturer05/18/2018
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage N
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
Patient Age63 YR
Patient Weight84
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