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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: UNKNOWN NEBULIZER; NEBULIZER (DIRECT PATIENT INTERFACE)
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UNKNOWN NEBULIZER; NEBULIZER (DIRECT PATIENT INTERFACE) Back to Search Results
Patient Problem Unspecified Respiratory Problem (4464)
Event Type  Injury  
Event Description
Patient reports was hospitalized (b)(6) 2023 for 2 weeks for cf (cystic fibrosis) tune up.Following has experienced unusual respiratory symptoms.Inhale 4 ml via nebulizer twice daily.
 
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Brand Name
NEBULIZER
Type of Device
NEBULIZER (DIRECT PATIENT INTERFACE)
Manufacturer (Section D)
UNKNOWN
MDR Report Key17541022
MDR Text Key321184065
Report NumberMW5144525
Device Sequence Number1
Product Code CAF
Combination Product (y/n)Y
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 08/09/2023
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/11/2023
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Patient Sequence Number1
Treatment
CAYSTON INH 75MG. ; FLUTICASONE SPR 50MCG.; NUCALA 100 MG/ML PEN.; NUCALA INJ 100MG/ML.; PULMOZYME 2.5MG/2.5MLNEB 90=30.; TOBRAMYCIN 300MG/5ML TOBI GEQ.; VITAMIN D CAP 50000UNT.
Patient Outcome(s) Hospitalization;
Patient SexFemale
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