MAUDE Adverse Event Report: INHALER, METERED DOSE OR DRY POWDER, CDER OR CBER LED

Lot Number 101501B

Device Problems Excess Flow or Over-Infusion (1311); Mechanics Altered (2984)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 07/25/2022

Event Type  malfunction  

Event Description

Button is stuck and when turn for dose, medication just sprays out.

• Brand Name: INHALER, METERED DOSE OR DRY POWDER, CDER OR CBER LED
• Type of Device: INHALER, METERED DOSE OR DRY POWDER, CDER OR CBER LED
• MDR Report Key: 15184400
• MDR Text Key: 297585172
• Report Number: MW5111330
• Device Sequence Number: 1
• Product Code: QKS
• UDI-Device Identifier: 00597015561
• UDI-Public: 00597015561
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Pharmacist
• Type of Report: Initial
• Report Date: 07/25/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/05/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Lot Number: 101501B
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Patient Sequence Number: 1
• Treatment: STIOLTO RESPIMAT
• Patient Age: 77 YR
• Patient Sex: Male