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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: PARAGON 28, INC. DEPTH GAUGE

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PARAGON 28, INC. DEPTH GAUGE Back to Search Results
Device Problem Output Problem (3005)
Patient Problem Insufficient Information (4580)
Event Date 06/23/2020
Event Type  malfunction  
Manufacturer Narrative
There is limited information for this complaint therefore, reportability is based on highest level of harm seen for failure mode. Identifying information, such as the part number and lot number of the device was not reported. Case information including related patient information was not provided by the initial reporter. Devices are not expected to be returned for the manufacturer review/investigation. If any further information is found which would change or alter any conclusions or information, a supplemental report will be filed accordingly.
 
Event Description
A post-market surveillance survey was completed on 06/25/2020, about a calc cuboid artho surgical procedure conducted on (b)(6) 2020. It was reported that a paragon 28 cannulated depth gauge did not work.
 
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Type of DeviceDEPTH GAUGE
Manufacturer (Section D)
PARAGON 28, INC.
14445 grasslands dr.
englewood CO 80112
Manufacturer Contact
victoria akinboboye
14445 grasslands dr.
englewood, CO 80112
MDR Report Key11600598
MDR Text Key244399159
Report Number3008650117-2021-00076
Device Sequence Number1
Product Code HTJ
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
Type of Report Initial
Report Date 03/31/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received03/31/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received06/25/2020
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? No Answer Provided
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unkown

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