RUSCH EMERALD FO MACINTOSH BLADE 004434400

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06,07 report with the FDA on 2014-05-30 for RUSCH EMERALD FO MACINTOSH BLADE 004434400 manufactured by Teleflex.

Event Text Entries

[20102600] The complaint is reported as: the customer alleges that the blade would not attach to the handle. The intubation was delayed until another laryngoscope set was obtained for pt use. No pt injury.
Patient Sequence No: 1, Text Type: D, B5


[20261507] The complaint sample is not available for investigation. A visual, functional and dimensional inspection was not be conducted due to lack of the device sample. The dhr (device history record) file is not available for review in the u. S. The complaint sample is not available for investigation. The complaint cannot be confirmed. No corrective/preventative actions will be assigned. The root cause cannot be determined.
Patient Sequence No: 1, Text Type: N, H10


MAUDE Entry Details

Report Number1044475-2014-00158
MDR Report Key3908240
Report Source06,07
Date Received2014-05-30
Date of Report2014-05-14
Date of Event2014-05-05
Date Mfgr Received2014-05-14
Date Added to Maude2014-07-16
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag0
Health Professional3
Initial Report to FDA3
Report to FDA0
Event Location0
Manufacturer ContactMARGIE BURTON, RN
Manufacturer StreetPO BOX 12600
Manufacturer CityRTP NC 27709
Manufacturer CountryUS
Manufacturer Postal27709
Manufacturer Phone9194334965
Manufacturer G1TELEFLEX
Manufacturer Street2917 WECK DR.
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameRUSCH EMERALD FO MACINTOSH BLADE
Generic NameLARYNGOSCOPE BLADE
Product CodeCAL
Date Received2014-05-30
Catalog Number004434400
OperatorOTHER
Device AvailabilityN
Device AgeDA
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerTELEFLEX
Manufacturer AddressRTP NC 27709 US 27709


Patients

Patient NumberTreatmentOutcomeDate
10 2014-05-30

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