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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BLISS HEALTH PRODUCTS CO., LTD ROSCOE; WALKER
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BLISS HEALTH PRODUCTS CO., LTD ROSCOE; WALKER Back to Search Results
Model Number WKAAWSLB
Device Problems Collapse (1099); Crack (1135)
Patient Problem Fall (1848)
Event Date 11/01/2017
Event Type  Injury  
Event Description
The end-user fell, and is in the hospital.The end-user's wife stated that the walker collapsed.The end-user has only used the walker inside to get to the restroom.This event occurred in the end-user's home on maple hardwood floors.The device involved with this event was returned to compass health brands & evaluated on (b)(6) 2017 - the customer's complaint could be confirmed from a review of the returned device.The returned unit was found to have its right open locking mechanism cracked and broken off - this component is plastic with a metal sleeve twisted into it - as a result, the leg is able to pivot to the closed position unintentionally.Again, the customer's complaint could be confirmed from a review of the returned device.
 
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Brand Name
ROSCOE
Type of Device
WALKER
Manufacturer (Section D)
BLISS HEALTH PRODUCTS CO., LTD
no. 96, zhaoyi rd.
dongsheng town
zhongshan city guangdong, 0
CH  0
MDR Report Key7064514
MDR Text Key93140586
Report Number3012316249-2017-00134
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 11/28/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/28/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Lay User/Patient
Device Model NumberWKAAWSLB
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? Yes
Date Report Sent to FDA11/28/2017
Distributor Facility Aware Date11/01/2017
Event Location Home
Date Report to Manufacturer11/28/2017
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 Age66 YR
Patient Weight98
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