MADGIC MAD700

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2010-03-11 for MADGIC MAD700 manufactured by Wolfe Tory Medical Inc..

Event Text Entries

[1441258] During the intubation procedure, the anesthesiologist used an atomization device to spray the patient's vocal cords with lidocaine. He placed the device in position and asked the nurse assisting him to spray the lidocaine by pushing the syringe. During this procedure, the nurse pushed and felt momentary resistance and then there was nothing. The syringe emptied too quickly and did not spray as usual. Anesthesiologist then got another atomization device and it appeared to function correctly. As nurse was throwing the two devices away, she noticed that one of them did not have the little plastic tip on the end of it, like the other one did. The anesthesiologist was notified and became concerned that the small plastic tip may have come off in the patient. The surgeon was notified and a laryngoscopy and flexible bronchoscopy was performed with no foreign object (plastic tip) noted. A chest x-ray was ordered and patient was monitored in recovery. No adverse patient affect. Had not seen this problem before but manufacturer found two other occurrences in their stock of products. Manufacturer response (as per reporter) for laryngo-tracheal mucosal atomization device, madgic manufacturer came to facility to pick up defective product for evaluation. Indicated assembly line staff have undergone retraining.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number1649632
MDR Report Key1649632
Date Received2010-03-11
Date of Report2010-03-11
Date of Event2010-02-26
Report Date2010-03-11
Date Reported to FDA2010-03-11
Date Added to Maude2010-04-05
Event Key0
Report Source CodeUser Facility report
Manufacturer LinkN
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag0
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Single Use0
Previous Use Code0
Event Type3
Type of Report3

Device Details

Brand NameMADGIC
Generic NameLARYNGO-TRACHEAL MUCOSAL ATOMIZATION DEVICE
Product CodeCCT
Date Received2010-03-11
Returned To Mfg2010-03-11
Model NumberMAD700
Catalog NumberMAD700
Lot Number00126A
ID Number*
OperatorPHYSICIAN
Device AvailabilityR
Device Age1 DY
Device Sequence No1
Device Event Key0
ManufacturerWOLFE TORY MEDICAL INC.
Manufacturer Address79 W. 4500 SOUTH, SUITE 18 SALT LAKE CITY UT 84107 US 84107


Patients

Patient NumberTreatmentOutcomeDate
10 2010-03-11

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