MAUDE Adverse Event Report: PARAGON 28, INC.; K-WIRE

Device Problem Patient Device Interaction Problem (4001)

Patient Problems Rash (2033); Blister (4537)

Event Date 12/27/2022

Event Type  Injury  

Manufacturer Narrative

Limited information is known about this event and the part information.

Event Description

It was reported that patient experienced titanium allergy from surgical implants.No allegation of device deficiency or device malfunction is associated with patient reaction.

• Type of Device: K-WIRE
• 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 Key: 16616005
• MDR Text Key: 312008475
• Report Number: 3008650117-2023-00063
• Device Sequence Number: 1
• Product Code: HXI
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 03/24/2023

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
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 02/23/2023
• Initial Date FDA Received: 03/24/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention