MAUDE Adverse Event Report: TUDORZA PRESSAIR INHALER

Device Problems Improper Flow or Infusion (2954); Mechanics Altered (2984); Application Program Problem: Medication Error (3198)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 06/02/2017

Event Type  malfunction  

Event Description

Patient called to report a product problem with her tudorza pressair inhaler.Patient stated that on (b)(6) 2017, the counting window that starts at 60 locked her out at 40 and failed to properly dispense the medication.Patient said she went to the pharmacy and the pharmacist called an (b)(4) rep and had them speak with the patient.Patient stated on (b)(6) 2017, she again had the same issue and again spoke with an (b)(6) rep who asked her if the device had been dropped or damaged, and told the patient not to tap the device with hands.Patient stated on (b)(6) 2017, she called the stride program to report that again the device is not dispensing the medication and is locking her out at 40 and 50.Patient said on (b)(6) 2018, once again the device locked her out and did not properly dispense her medication.The patient is concerned about the potential effects this could have on other people who depend on the medication.

• Brand Name: TUDORZA PRESSAIR INHALER
• Type of Device: INHALER
• MDR Report Key: 7305718
• MDR Text Key: 101487559
• Report Number: MW5075617
• Device Sequence Number: 1
• Product Code: KCO
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 02/28/2018

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?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 02/28/2018
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 72 YR