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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: TELEFLEX MEDICAL HUDSON NEBULIZER W/ADULT MASK & TBG, SMALL VOL; SMALL VOLUME NEBULIZER
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TELEFLEX MEDICAL HUDSON NEBULIZER W/ADULT MASK & TBG, SMALL VOL; SMALL VOLUME NEBULIZER Back to Search Results
Catalog Number 41893
Device Problem Restricted Flow rate (1248)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 04/09/2014
Event Type  malfunction  
Event Description
The event is reported as: the customer alleges that the mask does not mist.
 
Manufacturer Narrative
A visual, functional and dimensional inspection of the product involved in the complaint could not be conducted since the product was not returned.The device history record was reviewed and showed that there were no issues related to functional issues neither on the product nor its components during the manufacture of the material.A corrective action cannot be applied since it is not possible to identify the defect reported and to investigate its root cause, in order to perform a proper investigation it is necessary to evaluate the sample involved on the incident.If the defective sample becomes available, this investigation will be updated with the evaluation results.
 
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Brand Name
HUDSON NEBULIZER W/ADULT MASK & TBG, SMALL VOL
Type of Device
SMALL VOLUME NEBULIZER
Manufacturer (Section D)
TELEFLEX MEDICAL
nuevo laredo
MX 
Manufacturer Contact
margie burton, rn
p.o. box 12600
durham, NC 27709
9194334965
MDR Report Key3900223
MDR Text Key20696276
Report Number3004365956-2014-00180
Device Sequence Number1
Product Code CAF
Combination Product (y/n)N
Reporter Country CodeSF
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,User Facility,Company Representative
Reporter Occupation Nurse
Type of Report Initial
Report Date 04/11/2014
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/01/2014
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue Number41893
Device Lot Number02L1300155
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Date Manufacturer Received04/11/2014
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured11/01/2013
Is the Device Single Use? Yes
Type of Device Usage Initial
Patient Sequence Number1
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