ICU/O2 & AEROSOL/CATHETER 19035182

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,05,06,07 report with the FDA on 2014-05-29 for ICU/O2 & AEROSOL/CATHETER 19035182 manufactured by Unomedical S.r.o..

Event Text Entries

[4568917] It is reported while patient was undergoing diathermy during use of the product, a spark was generated which became a flame. The oxygen was turned on at a rate of 2 liters per min. The flame progressed through delivery device to patient resulting in superficial nostril burn. The patient recovered completely without any treatment and was discharged normally. It is reported that the incident affected two (2) elderly patients.
Patient Sequence No: 1, Text Type: D, B5


[12092408] Based on the available information, this event is deemed to be a serious injury. It is reported that both were outpatient procedures, but in different centers (they have two centers) by different surgeons. Both were excisions of in situ skin cancer near the nostril. In the other nostril, they had the catheter directing the oxygen flow. It is their routine procedure. When using the electrocauther, there was a spark and a flame which had never happened before. An investigation performed on (b)(4) 2011 based on evaluation of two (2) unused samples (lot no(s) 399286 and 401737) in closed peel pack were received and tested. The samples provided were tested, including visual test, measurements against the drawing and we determined that it met our specified requirements. In conclusion, the investigation of this matter has been done previously and the results are available in a documented corrective action preventative action (capa) event. Note: this is the first instance where the patient had a slight burn on the nostril. This case is related to patient dentifer #: (b)(6) reported under manufacturer's report #: 3005778470-2014-00031. No additional patient/event details have been provided to date. Should additional information become available, a follow-up report will be submitted. Note: this mdr is being reported as a result of a retrospective review of complaint records conducted by convatec for complaints received from (b)(4) 2011 - (b)(4) 2013. Reported to the fda on may 28, 2014. Convatec will continue to track and monitor such complaints according to convatec inc's complaint handling and capa procedures. (b)(4)
Patient Sequence No: 1, Text Type: N, H10


MAUDE Entry Details

Report Number3005778470-2014-00030
MDR Report Key3879462
Report Source01,05,06,07
Date Received2014-05-29
Date of Report2011-08-26
Date of Event2011-08-24
Date Mfgr Received2011-08-26
Date Added to Maude2014-06-19
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Reporter OccupationOTHER HEALTH CARE PROFESSIONAL
Health Professional3
Initial Report to FDA3
Report to FDA0
Event Location0
Manufacturer ContactMATTHEW WALENCIAK, ASSOCIATE DIR.
Manufacturer Street211 AMERICAN AVE
Manufacturer CityGREENSBORO NC 27409
Manufacturer CountryUS
Manufacturer Postal27409
Manufacturer Phone9083779293
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameICU/O2 & AEROSOL/CATHETER
Generic NameCATHETER, NASAL, OXYGEN
Product CodeBZB
Date Received2014-05-29
Returned To Mfg2011-09-22
Model Number19035182
Catalog Number19035182
Lot Number401737
OperatorHEALTH PROFESSIONAL
Device AvailabilityY
Device AgeDA
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
101. Required No Informationntervention 2014-05-29

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