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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: NINGBO SHENYU MEDICAL EQUIPMENT DRIVE; TOILET RAIL
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NINGBO SHENYU MEDICAL EQUIPMENT DRIVE; TOILET RAIL Back to Search Results
Model Number RTL12087
Medical Device Problem Code Loose or Intermittent Connection (1371)
Health Effect - Clinical Code Fall (1848)
Date of Event 09/21/2020
Type of Reportable Event Serious Injury
Event or Problem Description
Drive devilbiss is the initial importer of the device which is a toilet support rail.The device has not been received for evaluation.When the evaluation results are available a follow-up report will be filed.While using the device the right arm pin came out.The user fell down into the bath tub.The patient was hospitalized for three days.
 
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Brand Name
DRIVE
Common Device Name
TOILET RAIL
Manufacturer (Section D)
NINGBO SHENYU MEDICAL EQUIPMENT
west of tanjialing road
yuyao, zhejiang 31540 8
CH  315408
MDR Report Key10838639
Report Number2438477-2020-00058
Device Sequence Number4090039
Product Code ILS
UDI-Device Identifier50822383252846
UDI-Public50822383252846
Combination Product (Y/N)N
Initial Reporter StateMI
Initial Reporter CountryUS
Number of Events Summarized1
Summary Report (Y/N)N
Serviced by Third Party (Y/N)Unknown
Reporter Type Importer
Initial Reporter Occupation Other
Type of Report Initial
Report Date (Section B) 11/13/2020
Report Date (Section F) 11/13/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Operator of Device Lay User/Patient
Device Model NumberRTL12087
Was the Report Sent to FDA? Yes
Distributor Facility Aware Date10/23/2020
Device Age7 MO
Event Location Home
Date Report to Manufacturer11/16/2020
Initial Date Received by Manufacturer Not provided
Initial Report FDA Received Date11/13/2020
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
Outcome Attributed to Adverse Event Hospitalization;
Date Report Sent to FDA11/13/2020
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