OXYGEN W/FOAM 08/040CM/74BL0O + 19039052

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a distributor,foreign report with the FDA on 2015-11-06 for OXYGEN W/FOAM 08/040CM/74BL0O + 19039052 manufactured by Unomedical S.r.o..

Event Text Entries

[30639517] Convatec is submitting this report as a result of activities related to convatec remediation protocol (b)(4). Convatec is submitting this report pursuant to the provisions of 21cfr part 803. Blank fields on this form indicate the information is unknown, unavailable or unchanged. Any additional information received regarding this event after filing this report will be filed on a supplemental report (medwatch 3500a).
Patient Sequence No: 1, Text Type: N, H10


[30639518] Complainant reports "the oxygen catheter is not permeable" (blocked).
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number3005778470-2015-31241
MDR Report Key5208076
Report SourceDISTRIBUTOR,FOREIGN
Date Received2015-11-06
Date of Report2014-02-27
Date Mfgr Received2014-02-27
Date Added to Maude2015-11-06
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 FDA3
Event Location3
Manufacturer ContactJEANETTE JOHNSON
Manufacturer Street211 AMERICAN AVE
Manufacturer CityGREENSBORO NC 27409
Manufacturer CountryUS
Manufacturer Postal27409
Manufacturer Phone3362973009
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameOXYGEN W/FOAM 08/040CM/74BL0O +
Generic NameCATHETER, NASAL, OXYGEN
Product CodeBZB
Date Received2015-11-06
Returned To Mfg2011-11-15
Model Number19039052
Lot Number412678
Device AvailabilityR
Device Eval'ed by MfgrY
Device Sequence No1
Device Event Key0
ManufacturerUNOMEDICAL S.R.O.
Manufacturer AddressPRIEMYSELNY PARK 3 MICHALOVCE, 07101 LO 07101


Patients

Patient NumberTreatmentOutcomeDate
10 2015-11-06

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