MAUDE Adverse Event Report: ALBUTERAL SULFATE; NASAL SPRAY, ENT DELIVERY

Lot Number 1200480

Device Problem Product Quality Problem (1506)

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

Event Date 06/29/2023

Event Type  malfunction  

Event Description

Reporter called to report that his metered asthma inhaler stops working at 100 doses where, it is supposed to provide him with 200 doses.This is the second inhaler that has done this within the last couple of months.He has tried rinsing and cleaning it per user instruction but has been unsuccessful to get it to work to date.

• Brand Name: ALBUTERAL SULFATE
• Type of Device: NASAL SPRAY, ENT DELIVERY
• MDR Report Key: 17254056
• MDR Text Key: 318451251
• Report Number: MW5119086
• 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: 06/30/2023

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 Lot Number: 1200480
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 07/03/2023
• Patient Sequence Number: 1
• Patient Age: 76 YR
• Patient Sex: Male