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

MAUDE Adverse Event Report: COMPACT SPACE CHAMBER PLUS; COMPACT SPACE CHAMBER DEVICE

  • 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
 

COMPACT SPACE CHAMBER PLUS; COMPACT SPACE CHAMBER DEVICE Back to Search Results
Device Problem Device Operates Differently Than Expected (2913)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Type  Injury  
Event Description
Medication did not work for patient.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
COMPACT SPACE CHAMBER PLUS
Type of Device
COMPACT SPACE CHAMBER DEVICE
MDR Report Key7063919
MDR Text Key93221441
Report NumberMW5073595
Device Sequence Number1
Product Code NVP
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Physician
Type of Report Initial
Report Date 11/22/2017
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? No
Device Operator No Information
Is the Reporter a Health Professional? Yes
Was Device Evaluated by Manufacturer? No Information
Type of Device Usage N
Patient Sequence Number1
-
-