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

MAUDE Adverse Event Report: COMPASS HEALTH BRANDS CAREX; UPLIFT COMMODE ASSIST

  • 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
 

COMPASS HEALTH BRANDS CAREX; UPLIFT COMMODE ASSIST Back to Search Results
Model Number CCFCA200
Device Problem Material Fragmentation (1261)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Type  malfunction  
Event Description
Customer claims the ccfca200 is not working.Per the picture the customer provided, the tabs that attach the seat to the metal bracket onto the frame are broken.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
CAREX
Type of Device
UPLIFT COMMODE ASSIST
Manufacturer (Section D)
COMPASS HEALTH BRANDS
6753 engle road
middleburg heights,
Manufacturer (Section G)
COMPASS HEALTH BRANDS
6753 engle road
middleburg heights,
Manufacturer Contact
cynthia toney
6753 engle road
middleburg heights, 
2682110
MDR Report Key9716856
MDR Text Key206956182
Report Number3012316249-2020-00007
Device Sequence Number1
Product Code INN
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type distributor
Reporter Occupation Other
Type of Report Initial
Report Date 02/17/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/17/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator No Information
Device Model NumberCCFCA200
Was Device Available for Evaluation? No
Date Manufacturer Received02/23/2019
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unknown
Patient Sequence Number1
-
-