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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: UNOMEDICAL S.R.O. PURI W.FEED.CON05/040CM/PUR 2C +; TUBE, FEEDING
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UNOMEDICAL S.R.O. PURI W.FEED.CON05/040CM/PUR 2C +; TUBE, FEEDING Back to Search Results
Model Number 31001181
Device Problems Break (1069); Occlusion Within Device (1423); Defective Device (2588)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 09/17/2012
Event Type  malfunction  
Manufacturer Narrative
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.Any additional information received regarding this event after filing this report will be filed on a supplemental report (medwatch 3500a).
 
Event Description
Complainant reports "there are no holes so the feeding could not pass through and the cap is lose, can not keep closed during use.".
 
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Brand Name
PURI W.FEED.CON05/040CM/PUR 2C +
Type of Device
TUBE, FEEDING
Manufacturer (Section D)
UNOMEDICAL S.R.O.
priemyselny park 3
michalovce, 07101
LO  07101
Manufacturer Contact
jeanette johnson
211 american ave
greensboro, NC 27409
3362973009
MDR Report Key5208153
MDR Text Key30643116
Report Number3005778470-2015-31288
Device Sequence Number1
Product Code FPD
Combination Product (y/n)N
Reporter Country CodeDA
PMA/PMN Number
K896734
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,health professional
Reporter Occupation Health Professional
Type of Report Initial
Report Date 02/27/2014
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/06/2015
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator No Information
Device Expiration Date08/01/2016
Device Model Number31001181
Device Lot Number422379
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer10/01/2012
Is the Reporter a Health Professional? Yes
Date Manufacturer Received02/27/2014
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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