MAUDE Adverse Event Report: TD-100; INHALER, NASAL

Device Problem Loss of Power (1475)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/07/2018

Event Type  malfunction  

Event Description

Patient reports that td-100 device shuts off in the middle of his treatments and needs to power it back on in order to finish.Pt has not experienced any ade due to device.Pt does have back up device that is working properly.Pt initially declined offer to ship replacement device.Cnss sent e-mail to the pharmacy that a new device be sent to the patient.Pharmacy is reaching out to patient to schedule shipment of replacement device.Serial number of device in question: (b)(4).No other information known.Dates of use: (b)(6) 2018 to ongoing.Diagnosis or reason for use: pah.(b)(4).

• Brand Name: TD-100
• Type of Device: INHALER, NASAL
• MDR Report Key: 7600683
• MDR Text Key: 111305050
• Report Number: MW5077859
• Device Sequence Number: 1
• Product Code: KCO
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Pharmacist
• Type of Report: Initial
• Report Date: 06/07/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 06/13/2018
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 74 YR