TUDORZA PRESSAIR INHALER

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-02-28 for TUDORZA PRESSAIR INHALER manufactured by Unk.

Event Text Entries

[101487559] 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.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: MW5075617
• MDR Report Key: 7305718
• Date Received: 2018-02-28
• Date of Report: 2018-02-28
• Date of Event: 2017-06-02
• Date Added to Maude: 2018-03-01
• Event Key: 0
• Report Source Code: Voluntary report
• Manufacturer Link: N
• Number of Patients in Event: 0
• Adverse Event Flag: 3
• Product Problem Flag: 3
• Reprocessed and Reused Flag: 3
• Reporter Occupation: PATIENT
• Health Professional: 3
• Initial Report to FDA: 3
• Report to FDA: 3
• Event Location: 3
• Single Use: 3
• Previous Use Code: 3
• Event Type: 3
• Type of Report: 0

Device Details

• Brand Name: TUDORZA PRESSAIR INHALER
• Generic Name: INHALER
• Product Code: KCO
• Date Received: 2018-02-28
• Device Availability: *
• Device Eval'ed by Mfgr: I
• Device Sequence No: 1
• Device Event Key: 0
• Manufacturer: UNK

Patients

Patient Number	Treatment	Outcome	Date
1	0		2018-02-28