RUSCH RR MAGIL/CUFFED ET TUBE, 3.0MM 102000030

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,06,07 report with the FDA on 2012-12-06 for RUSCH RR MAGIL/CUFFED ET TUBE, 3.0MM 102000030 manufactured by Willy Rusch Gmbh.

Event Text Entries

[2899099] The event is reported as: the customer alleges that et tube has a defect and it seems to be leaky. Patient is fine. No report of a patient injury.
Patient Sequence No: 1, Text Type: D, B5


[10411713] The device sample was not returned for evaluation at the time of this report.
Patient Sequence No: 1, Text Type: N, H10


MAUDE Entry Details

Report Number9610520-2012-00017
MDR Report Key2864481
Report Source01,06,07
Date Received2012-12-06
Date of Report2012-11-21
Date of Event2012-11-01
Date Mfgr Received2012-11-21
Date Added to Maude2013-03-13
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Health Professional3
Initial Report to FDA3
Report to FDA0
Event Location0
Manufacturer ContactMARGIE BURTON, RN, CLINICAL SPEC
Manufacturer StreetPO BOX 12600
Manufacturer CityDURHAM NC 27709
Manufacturer CountryUS
Manufacturer Postal27709
Manufacturer Phone9194334965
Manufacturer G1WILLY RUSCH GMBH
Manufacturer StreetWILLY RUSCH-STR. 4-10
Manufacturer CityKERNEN 71394
Manufacturer CountryGM
Manufacturer Postal Code71394
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameRUSCH RR MAGIL/CUFFED ET TUBE, 3.0MM
Generic NameRED RUBBER ENDOTRACHEAL TUBE
Product CodeBYW
Date Received2012-12-06
Catalog Number102000030
OperatorOTHER
Device AvailabilityY
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerWILLY RUSCH GMBH
Manufacturer AddressKERNEN GM


Patients

Patient NumberTreatmentOutcomeDate
10 2012-12-06

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