MAUDE Adverse Event Report: NEBULIZER; NEBULIZER (DIRECT PATIENT INTERFACE)

Patient Problem Asthma (1726)

Event Date 09/25/2023

Event Type  Injury  

Event Description

I started to have an acute asthma attack and have been a long time diagnosed asthmatic (last 24 years or so) and although i had prescriptions waiting for albuterol packs and a rescue inhaler, i was denied any access to one.The pharmacy said i needed an additional prescription and from my pcp in order to get a nebulizer.I called my pcp several times over the course of 48 hours and still ended up in an emergency room.Will likely end up there again today because even though i have the medicine my machine stopped working and needs replacement.This is a huge barrier to accessing care and could kill someone.I implore the fda to seriously rethink the need for a patient to also have a script to purchase hardware to take their prescription medication- complete nonsense and a scary experience.

• Brand Name: NEBULIZER
• Type of Device: NEBULIZER (DIRECT PATIENT INTERFACE)
• MDR Report Key: 17859870
• MDR Text Key: 324866920
• Report Number: MW5146374
• Device Sequence Number: 1
• Product Code: CAF
• 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: 09/27/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/29/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Patient Sequence Number: 1
• Treatment: ALBUTEROL; INHALER
• Patient Outcome(s): Life Threatening
• Patient Age: 38 YR
• Patient Sex: Female
• Patient Ethnicity: Non Hispanic
• Patient Race: White