MAUDE Adverse Event Report: WOLFE TORY/TELEFLEX HUDSON MADGIC ATOMIZER WITHOUT SYRINGE; NASAL ATOMIZER

Catalog Number MAD700

Device Problem Detachment Of Device Component (1104)

Patient Problems No Known Impact Or Consequence To Patient (2692); No Code Available (3191)

Event Date 06/24/2014

Event Type  malfunction  

Event Description

The event is reported as: the customer alleges that the tip of the mad700 came off during atomization and was located and removed from the pt's epiglottis.

Manufacturer Narrative

The device sample was not returned for eval at the time of this report.

• 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, regulatory af ; p.o. box 12600; durham, NC 27709 ; 9194334965
• MDR Report Key: 4163174
• MDR Text Key: 4772899
• Report Number: 1722554-2014-00001
• Device Sequence Number: 1
• Product Code: CCQ
• Combination Product (y/n): N
• Reporter Country Code: AS
• Number of Events Reported: 1
• 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: 07/02/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: MAD700
• Device Lot Number: 131143
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 07/02/2014
• Initial Date FDA Received: 07/16/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1