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

Device Problem Patient Device Interaction Problem (4001)

Patient Problems Itching Sensation (1943); Peeling (1999); Rash (2033); Ulcer (2274); Skin Inflammation/ Irritation (4545)

Event Date 11/09/2021

Event Type  Injury  

Event Description

I was prescribed ipratropium bromide inhalation solution and albuterol solution used in a nebulizer.First i used the plastic tube and tip for this treatment on my nebulizer, however got painful sore in my mouth.Then i started using a mask, which caused severe rash, itching dryness skin flaking.I knew then this severe reaction was coming from the above medication used in the nebulizer.Fda safety report id# (b)(4).

• Brand Name: NEBULIZER
• Type of Device: NEBULIZER (DIRECT PATIENT INTERFACE)
• MDR Report Key: 12829910
• MDR Text Key: 281003907
• Report Number: MW5105397
• 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: 11/14/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/16/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Was Device Available for Evaluation?: Yes
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 77 YR
• Patient Sex: Female
• Patient Weight: 68 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White