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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: LERADO GLOBAL DAILY ACTIVITY ASSIST DEVICES; 890.5050

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LERADO GLOBAL DAILY ACTIVITY ASSIST DEVICES; 890.5050 Back to Search Results
Model Number 6418
Device Problem Unstable (1667)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Type  No Answer Provided  
Event Description
Provider alleged the base of the device is not threaded.
 
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Brand Name
DAILY ACTIVITY ASSIST DEVICES
Type of Device
890.5050
Manufacturer (Section D)
LERADO GLOBAL
no. 26-54b,
7andar h7 edif. centro com
macau
CH 
MDR Report Key4110908
MDR Text Key4700091
Report Number1531186-2014-04357
Device Sequence Number1
Product Code ILS
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Invalid Data
Reporter Occupation Medical Equipment Company Technician/Representative
Type of Report Initial
Report Date 09/23/2014,09/03/2014
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Lay User/Patient
Device Model Number6418
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? Yes
Date Report Sent to FDA09/23/2014
Distributor Facility Aware Date09/03/2014
Device Age6 MO
Date Report to Manufacturer09/23/2014
Initial Date Manufacturer Received Not provided
Initial Date FDA Received09/23/2014
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Other;
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