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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ALTERA HANDSET; NEBULIZER (DIRECT PATIENT INTERFACE)
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ALTERA HANDSET; NEBULIZER (DIRECT PATIENT INTERFACE) Back to Search Results
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Type  malfunction  
Event Description
Spontaneous call from pt to report that device does not seem to be working well.She did not state it was adversely affecting her.Pt is not sure her insurance will pay for another device.No other info known.Reported to (b)(6) by pt/caregiver.
 
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Brand Name
ALTERA HANDSET
Type of Device
NEBULIZER (DIRECT PATIENT INTERFACE)
MDR Report Key9506293
MDR Text Key172566125
Report NumberMW5091834
Device Sequence Number1
Product Code CAF
Combination Product (y/n)Y
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 12/11/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/19/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator No Information
Is the Reporter a Health Professional? Yes
Was Device Evaluated by Manufacturer? No Information
Type of Device Usage N
Patient Sequence Number1
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