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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: WOLFE TORY/TELEFLEX HUDSON MADGIC ATOMIZER WITHOUT SYRINGE; NASAL ATOMIZER
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WOLFE TORY/TELEFLEX HUDSON MADGIC ATOMIZER WITHOUT SYRINGE; NASAL ATOMIZER Back to Search Results
Catalog Number MAD510
Device Problem Component Missing (2306)
Patient Problems No Known Impact Or Consequence To Patient (2692); No Information (3190); No Code Available (3191)
Event Date 07/01/2014
Event Type  malfunction  
Event Description
The event is reported as: the customer alleges that the tip of the madomizer is missing.The customer reports that they thought that the tip was missing before the product was used on a patient and noticed a jet of drug from the device rather than a spray.The anesthetist withdrew the nozzle from the patient and the tip was missing.A bronchoscopy was performed in search for the tip.The bronchoscopy was negative.
 
Manufacturer Narrative
The device sample was not returned for evaluation at the time of this report.
 
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Brand Name
HUDSON MADGIC ATOMIZER WITHOUT SYRINGE
Type of Device
NASAL ATOMIZER
Manufacturer (Section D)
WOLFE TORY/TELEFLEX
salt lake city UT 84107
Manufacturer (Section G)
WOLFE TORY MEDICAL, INC.
79 west 4500 south
suite 18
salt lake city UT 84107
Manufacturer Contact
margie burton, rn
p.o. box 12600
durham, NC 27709
9194334965
MDR Report Key4174413
MDR Text Key21495377
Report Number1722554-2014-00002
Device Sequence Number1
Product Code CCQ
Combination Product (y/n)N
Reporter Country CodeAS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Other,Foreign,Health Professional,User Facility,Company Representative
Reporter Occupation Nurse
Type of Report Initial
Report Date 07/18/2014
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/11/2014
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue NumberMAD510
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Date Manufacturer Received07/18/2014
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? Yes
Type of Device Usage Initial
Patient Sequence Number1
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