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

MAUDE Adverse Event Report: PARAGON 28, INC. PHANTOM HINDFOOT TTC/TC NAIL SYSTEM

  • 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
 

PARAGON 28, INC. PHANTOM HINDFOOT TTC/TC NAIL SYSTEM Back to Search Results
Device Problem Patient Device Interaction Problem (4001)
Patient Problem Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)
Event Date 04/04/2022
Event Type  Injury  
Event Description
Patient reaction experienced with no allegation of product deficiency.
 
Manufacturer Narrative
(b)(4).
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NamePHANTOM HINDFOOT TTC/TC NAIL SYSTEM
Type of DevicePHANTOM HINDFOOT TTC/TC NAIL SYSTEM
Manufacturer (Section D)
PARAGON 28, INC.
14445 grasslands dr.
englewood CO 80112
Manufacturer Contact
victoria akinboboye
14445 grasslands dr.
englewood, CO 80112
7207165439
MDR Report Key14297156
MDR Text Key291317887
Report Number3008650117-2022-00050
Device Sequence Number1
Product Code HSB
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Company Representative
Reporter Occupation Non-Healthcare Professional
Type of Report Initial
Report Date 05/04/2022
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received05/06/2022
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Was Device Available for Evaluation? No Answer Provided
Date Manufacturer Received04/11/2022
Was Device Evaluated by Manufacturer? No

-
-