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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: TELEFLEX HUDSON MICRO MIST SMALL VOLUME NEBULIZER; ADULT SMALL VOLUME NEBULIZER
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TELEFLEX HUDSON MICRO MIST SMALL VOLUME NEBULIZER; ADULT SMALL VOLUME NEBULIZER Back to Search Results
Catalog Number 41893
Device Problem Partial Blockage (1065)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 07/03/2014
Event Type  malfunction  
Event Description
The complaint is reported as: the nebulizer was blocked.It did not mist.They opened and used a new set." the pt condition was reported as fine.
 
Manufacturer Narrative
The device history record of batch number 02e1300978 was reviewed and there were no issues or discrepancies found that could relate to the reported complaint.No non-conformance reports were originated for the lot in question.The dhr shows that the product was assembled and inspected according to specifications.The sample was not returned for evaluation, therefore, the complaint could not be confirmed.If the sample is returned, a follow-up report will be submitted with investigation results.
 
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Brand Name
HUDSON MICRO MIST SMALL VOLUME NEBULIZER
Type of Device
ADULT SMALL VOLUME NEBULIZER
Manufacturer (Section D)
TELEFLEX
nuevo laredo
MX 
Manufacturer Contact
katharine tarpley
p.o. box 12600
rtp, NC 27709
9194334854
MDR Report Key3994383
MDR Text Key4891909
Report Number3004365956-2014-00286
Device Sequence Number1
Product Code CCQ
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 Not Applicable
Type of Report Initial
Report Date 07/07/2014
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/23/2014
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other
Device Catalogue Number41893
Device Lot Number02E1300978
Was Device Available for Evaluation? Yes
Date Manufacturer Received07/07/2014
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured05/01/2013
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
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