MAUDE Adverse Event Report: UNKNOWN ALBUTEROL SULFATE 90MCG; NEBULIZER (DIRECT PATIENT INTERFACE)

Patient Problems Chest Pain (1776); Dizziness (2194); Unspecified Respiratory Problem (4464)

Event Type  malfunction  

Event Description

My inhaler was defective.I have copd, when using the inhaler my chest became tight, with slight chest pains.I also became dizzy.I contacted my doctor and she stated that the inhaler was dispensing more medication than the recommended dosage.My inhaler was immediately changed.Cipla ltd.2 puffs by mouth 2x a day.2x a day by mouth.

• Brand Name: ALBUTEROL SULFATE 90MCG
• Type of Device: NEBULIZER (DIRECT PATIENT INTERFACE)
• Manufacturer (Section D): UNKNOWN
• MDR Report Key: 17586408
• MDR Text Key: 321725968
• Report Number: MW5144799
• Device Sequence Number: 1
• Product Code: CAF
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Unknown
• Type of Report: Initial
• Report Date: 07/14/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/18/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Was Device Available for Evaluation?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Sex: Female
• Patient Weight: 68 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: Black Or African American