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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: AIKIN HOLDING CORP. PROBASICS; ROLLATOR
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AIKIN HOLDING CORP. PROBASICS; ROLLATOR Back to Search Results
Model Number PB1025LP
Device Problem Unstable (1667)
Patient Problems Head Injury (1879); Hematoma (1884)
Event Date 12/19/2019
Event Type  Injury  
Event Description
End-user called in about a rollator she had for two years.She stated she has since taken the device back to where she purchased it from multiple times for repairs.The left front wheel is bent in, causing the wheel to become very wobbly.On (b)(6) 2019, the end-user was at home walking thru the hallway, and the wheel became very unstable.The end-user hit her head on the wall.She stated that due to hitting her head, it caused a big hematoma on the front of her head.Paramedics were called to the scene, and she was taken to the hospital where staff performed a catscan.The catscan results came back normal.She was given something for pain, and was discharged.The wheel is noted as still being attached to the rollator.
 
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Brand Name
PROBASICS
Type of Device
ROLLATOR
Manufacturer (Section D)
AIKIN HOLDING CORP.
4f., no. 8, lane 86, he ping r
hsinchu hsinchu-municipality
TW 
MDR Report Key8287267
MDR Text Key134417048
Report Number3012316249-2019-00003
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 01/29/2019
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? Yes
Device Operator Lay User/Patient
Device Model NumberPB1025LP
Was Device Available for Evaluation? No
Was the Report Sent to FDA? Yes
Date Report Sent to FDA01/29/2019
Distributor Facility Aware Date01/10/2019
Event Location Home
Date Report to Manufacturer01/29/2019
Initial Date Manufacturer Received Not provided
Initial Date FDA Received01/29/2019
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage N
Patient Sequence Number1
Patient Outcome(s) Other; Required Intervention;
Patient Age75 YR
Patient Weight68
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