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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MAXHEALTH CORP. PROBASICS; KNEE WALKER

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MAXHEALTH CORP. PROBASICS; KNEE WALKER Back to Search Results
Model Number PB1030KW
Device Problems Loose or Intermittent Connection (1371); Device Dislodged or Dislocated (2923); Mechanics Altered (2984)
Patient Problems Fall (1848); Headache (1880); Pain (1994)
Event Date 05/12/2017
Event Type  Injury  
Event Description
This incident occurred on a replacement knee walker device when the end-user was at a doctor's appointment.The screws backed out of the knee walker, and its handlebars twisted one way while its wheels went another.The user said she is having neck pain and migraines since the incident, along with back pain.She was having to see a neurologist and was getting injections in her back for the pain; the knee walker had loose central bolts used to align the handlebars with the wheels, which may have contributed to the user falling while on her way into the doctor's office.The knee walker involved with this event has been reported with either serial number (b)(4) or (b)(4) but it is unclear serial number actually applies.
 
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Brand Name
PROBASICS
Type of Device
KNEE WALKER
Manufacturer (Section D)
MAXHEALTH CORP.
15f-6, no. 81, sec. 1, hsin
tai wu road, hsi chih
taipei hsien, 221
TW  221
MDR Report Key6845186
MDR Text Key84995704
Report Number3012316249-2017-00111
Device Sequence Number1
Product Code ITJ
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Distributor
Type of Report Initial
Report Date 09/06/2017
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 NumberPB1030KW
Device Catalogue Number#1030
Was Device Available for Evaluation? No
Was the Report Sent to FDA? Yes
Date Report Sent to FDA09/06/2017
Distributor Facility Aware Date06/23/2017
Event Location Other
Date Report to Manufacturer09/06/2017
Initial Date Manufacturer Received Not provided
Initial Date FDA Received09/06/2017
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage N
Patient Sequence Number1
Patient Outcome(s) Other;
Patient Weight94
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