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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CONVATEC, INC S2S/SUR-FIT NATURA 2 PC - 2 PC DRAINABLE POUCH; POUCH, COLOSTOMY
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CONVATEC, INC S2S/SUR-FIT NATURA 2 PC - 2 PC DRAINABLE POUCH; POUCH, COLOSTOMY Back to Search Results
Model Number 401507
Device Problem Device Markings/Labelling Problem (2911)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 02/22/2012
Event Type  malfunction  
Event Description
Report received indicated that the label was missing from the box upon receipt.Product was never used and there was no pt involvement.
 
Manufacturer Narrative
Convatec is submitting this report as a result of remediation activities related to the fda 483 issued 04/16/2014.Device(s) listed in this report is (are) used for treatment, not diagnosis.Any add'l info received regarding this event after filing this report shall be filed on a supplemental mdr.A review of complaint trend for previous 12 months was performed and this is the only complaint of this type for this icc code.There is no indication of complaint trend based on this review.
 
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Brand Name
S2S/SUR-FIT NATURA 2 PC - 2 PC DRAINABLE POUCH
Type of Device
POUCH, COLOSTOMY
Manufacturer (Section D)
CONVATEC, INC
211 american ave
greensboro NC
Manufacturer Contact
matthew walenciak, dir, post mark
211 american ave
greensboro, NC 27409
9083779293
MDR Report Key4051709
MDR Text Key19087308
Report Number9618003-2014-10514
Device Sequence Number1
Product Code EZQ
Combination Product (y/n)N
PMA/PMN Number
K833625
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Company Representative
Type of Report Initial
Report Date 02/22/2012
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/08/2014
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other
Device Model Number401507
Was Device Available for Evaluation? No
Date Manufacturer Received02/22/2012
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? No
Type of Device Usage Unknown
Patient Sequence Number1
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