Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DANYANG MAXTHAI MEDICAL EQUIPMENT ROLLITE ROLLATOR 9153637242; WALKER, MECHANICAL
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

DANYANG MAXTHAI MEDICAL EQUIPMENT ROLLITE ROLLATOR 9153637242; WALKER, MECHANICAL Back to Search Results
Model Number 65650
Device Problem Deformation Due to Compressive Stress (2889)
Patient Problems Bruise/Contusion (1754); Laceration(s) (1946)
Event Date 02/01/2016
Event Type  Injury  
Event Description
Reporter advised father uses the rollator.Reporter advised father was in living room going to the restroom and frame near right rear caster bent and caused enduser to fall to the floor.Reporter advised father went down with rollator and fell on top of it and metal piece that broke caught enduser right forearm and cut it open and was bleeding and bruises on middle of chest.Reporter advised family helped enduser up and they took him to the (b)(6) emergency room in (b)(6).Reporter advised father received seven stitches on forearm, x rays was done on chest and no fractures or breaks just bruises.Reporter advised emergency room advised to put neosporin on it and change bandages.Reporter advised injury happened at the beginning of the month but could not advised exact date.Reporter advised borrowed a rollator that they have to return.Reporter advised stitches were taken out the week of (b)(6), 2016 and he still has bruises.Reporter could not provide any further information.
 
Manufacturer Narrative
Product was returned for evaluation.The return fields in oracle state: rollators.Release other, hold for detailed evaluation.Product received expanded evaluation.The expanded evaluation report states: utilizing existing complaint information, actual observations, and functional testing of the returned product in its "as received" condition, the complaint was confirmed for the economy rollator of having a fractured right side frame just above the right, rear wheel.There was deformation above and at the site of the fracture indicative of the rollator being overloaded on the right side.Complaint was confirmed.The underlying cause could not be determined after reviewing the documentation in this investigation.
 
Event Description
Product was returned for evaluation.The return fields in oracle state: rollators.Release other, hold for detailed evaluation.Product received expanded evaluation.The expanded evaluation report states: utilizing existing complaint information, actual observations, and functional testing of the returned product in its "as received" condition, the complaint was confirmed for the economy rollator of having a fractured right side frame just above the right, rear wheel.There was deformation above and at the site of the fracture indicative of the rollator being overloaded on the right side.Reporter advised father uses the rollator.Reporter advised father was in living room going to the restroom and frame near right rear caster bent and caused enduser to fall to the floor.Reporter advised father went down with rollator and fell on top of it and metal piece that broke caught enduser right forearm and cut it open and was bleeding and bruises on middle of chest.Reporter advised family helped enduser up and they took him to (b)(6).Reporter advised father received seven stitches on forearm, x rays was done on chest and no fractures or breaks just bruises.Reporter advised emergency room advised to put neosporin on it and change bandages.Reporter advised injury happened at the beginning of the month but could not advised exact date.Reporter advised borrowed a rollator that they have to return.Reporter advised stitches were taken out (b)(6) 2016 and he still has bruises.Reporter could not provide any further information.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
ROLLITE ROLLATOR 9153637242
Type of Device
WALKER, MECHANICAL
Manufacturer (Section D)
DANYANG MAXTHAI MEDICAL EQUIPMENT
danyang
CH 
MDR Report Key5467409
MDR Text Key39267516
Report Number1531186-2016-00007
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 Patient Family Member or Friend
Type of Report Initial,Followup
Report Date 04/15/2016,04/14/2016
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 Number65650
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer04/14/2016
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? Yes
Date Report Sent to FDA04/15/2016
Distributor Facility Aware Date04/14/2016
Device Age5 YR
Event Location Home
Date Report to Manufacturer04/15/2016
Initial Date Manufacturer Received Not provided
Initial Date FDA Received02/29/2016
Supplement Dates Manufacturer ReceivedNot provided
Supplement Dates FDA Received04/20/2016
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage N
Patient Sequence Number1
Patient Outcome(s) Hospitalization;
Patient Weight118
-
-