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: REBORN MEDICAL CO., LTD DRIVE MEDICAL; MECHANICAL WALKER
  • 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
 

REBORN MEDICAL CO., LTD DRIVE MEDICAL; MECHANICAL WALKER Back to Search Results
Model Number 10210-1
Device Problem Fracture (1260)
Patient Problem Tooth Fracture (2428)
Event Date 12/27/2014
Event Type  Injury  
Event Description
Drive medical received notification from an attorney of an adverse incident regarding a walker that drive medical imports and distributes.Drive medical contacted the attorney to gather more info.Attorney states that his client was using the walker the same day it was provided to him and the metal from the top handle allegedly broke.Client allegedly fell and broke/chipped three teeth.This report is based on info provided by the attorney.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
DRIVE MEDICAL
Type of Device
MECHANICAL WALKER
Manufacturer (Section D)
REBORN MEDICAL CO., LTD
guangdong
CH 
Manufacturer (Section G)
MEDICAL DEPOT
99 seaview blvd.
port washington NY 11050
Manufacturer Contact
99 seaview blvd.
port washington, NY 11050
MDR Report Key4620764
MDR Text Key19800928
Report Number2438477-2015-00007
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
Source Type Unknown
Reporter Occupation Not Applicable
Type of Report Initial
Report Date 02/20/2015,01/21/2015
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? No
Device Operator Lay User/Patient
Device Model Number10210-1
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? No
Distributor Facility Aware Date01/21/2015
Device AgeYR
Event Location Home
Date Report to Manufacturer02/20/2015
Initial Date Manufacturer Received Not provided
Initial Date FDA Received02/23/2015
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Other;
Patient Age79 YR
-
-