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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: UNKNOWN DAILY ACTIVITY ASSIST DEVICES; 890.5050

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UNKNOWN DAILY ACTIVITY ASSIST DEVICES; 890.5050 Back to Search Results
Model Number 1301RTS
Device Problems Break (1069); Unstable (1667)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Type  No Answer Provided  
Event Description
It was reported by the end user's nephew that the clamp which secures the commode to the toilet is not screwing closed.Per the user's manual-warning: always make sure that the raised toilet seat is securely in place and stable before each use.Although the raised toilet seat is designed for use on most popular toilets, it may not work on certain unusual or artistic bowls.No patient injury reported, no additional information provided.
 
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Brand Name
DAILY ACTIVITY ASSIST DEVICES
Type of Device
890.5050
Manufacturer (Section D)
UNKNOWN
OH
MDR Report Key4120841
MDR Text Key21241468
Report Number1531186-2014-04478
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 Patient Family Member or Friend
Type of Report Initial
Report Date 09/26/2014,09/03/2014
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 Number1301RTS
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? Yes
Date Report Sent to FDA09/26/2014
Distributor Facility Aware Date09/03/2014
Date Report to Manufacturer09/26/2014
Initial Date Manufacturer Received Not provided
Initial Date FDA Received09/26/2014
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Other;
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