• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: GENTEEL HOMECARE PRODUCTS MECHANICAL WALKER, ROLLATOR; 890.3825

  • 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
 

GENTEEL HOMECARE PRODUCTS MECHANICAL WALKER, ROLLATOR; 890.3825 Back to Search Results
Model Number 68100-TA
Device Problem Unstable (1667)
Patient Problems Fall (1848); Discomfort (2330)
Event Date 10/30/2014
Event Type  No Answer Provided  
Event Description
Dealer stated that the 68100-ta rollator is wobbly left to right, unit cannot be tightened.End user reported that the rollator had been a little wobbly and he was using the unit with the seat down to try and make it more sturdy.User also reported that he missed a step outside a hotel and fell on the rollator, thus making the unit a lot more wobbly after the accident.User reported that his right knee was hurt due to the falling accident, was in the hospital for a day or two and then transferred to rehab for 10 days.He will require rehab in the home twice a week.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
MECHANICAL WALKER, ROLLATOR
Type of Device
890.3825
Manufacturer (Section D)
GENTEEL HOMECARE PRODUCTS
liyu industry area
danzao nanhai foshan 5282 16
CH  528216
MDR Report Key4242418
MDR Text Key4990086
Report Number1531186-2014-05516
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 Manufacturer
Source Type Invalid Data
Reporter Occupation Medical Equipment Company Technician/Representative
Type of Report Initial
Report Date 11/11/2014,11/10/2014
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 Number68100-TA
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? Yes
Date Report Sent to FDA11/11/2014
Distributor Facility Aware Date11/10/2014
Device Age5 MO
Date Report to Manufacturer11/11/2014
Initial Date Manufacturer Received Not provided
Initial Date FDA Received11/11/2014
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Other;
-
-