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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: UNOMEDICAL S.R.O. OXYGEN W/FOAM 10/040CM/71DG0O +; CATHETER, NASAL, OXYGEN
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UNOMEDICAL S.R.O. OXYGEN W/FOAM 10/040CM/71DG0O +; CATHETER, NASAL, OXYGEN Back to Search Results
Model Number 19055339
Device Problems Kinked (1339); Packaging Problem (3007)
Patient Problem No Patient Involvement (2645)
Event Type  malfunction  
Manufacturer Narrative
Convatec is submitting this report as a result of activities related to convatec remediation protocol (b)(4) and protocol (b)(4).Convatec is submitting this report pursuant to the provisions of 21cfr part 803.Any additional information received regarding this event after filing this report will be filed on a supplemental report (medwatch 3500a).
 
Event Description
Complainant reports "kinks in the tube.".
 
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Brand Name
OXYGEN W/FOAM 10/040CM/71DG0O +
Type of Device
CATHETER, NASAL, OXYGEN
Manufacturer (Section D)
UNOMEDICAL S.R.O.
priemyselny park 3
michalovce, 07101
LO  07101
Manufacturer Contact
jeanette johnson
7900 triad center drive
greensboro, NC 27409
3365424681
MDR Report Key5291115
MDR Text Key33328036
Report Number3005778470-2015-40057
Device Sequence Number1
Product Code BZB
Combination Product (y/n)N
Reporter Country CodeGM
PMA/PMN Number
K896731
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type distributor,foreign
Reporter Occupation Other
Type of Report Initial
Report Date 11/06/2015
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/11/2015
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other
Device Expiration Date12/01/2017
Device Model Number19055339
Device Lot Number463296
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer03/11/2013
Is the Reporter a Health Professional? No
Date Manufacturer Received11/06/2015
Was Device Evaluated by Manufacturer? Yes
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unknown
Patient Sequence Number1
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