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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CONVATEC DOMINICAN REPUBLIC, INC. S2S/SUR-FIT NATURA 2 PC - 2 PC DRAINABLE POUCH HIGH OUTPUT W/FILTER; POUCH, COLOSTOMY

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CONVATEC DOMINICAN REPUBLIC, INC. S2S/SUR-FIT NATURA 2 PC - 2 PC DRAINABLE POUCH HIGH OUTPUT W/FILTER; POUCH, COLOSTOMY Back to Search Results
Model Number 401557
Device Problem Leak/Splash (1354)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Type  malfunction  
Event Description
Report received indicated the pouch leaked from the seam at the bottom of the pouch.No further information was provided and the patient outcome was not reported.
 
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 additional information received regarding this event after filing this report shall be filed on a supplemental mdr.Investigation revealed that a probable root cause was determined to be associated with the creation of an arch during the outline weld.A new outline weld tooling design was implemented to prevent reoccurrence."leaked at seams" complaint information will continue to be tracked and evaluated according to convatec, inc.Complaint monitoring procedures.
 
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Brand Name
S2S/SUR-FIT NATURA 2 PC - 2 PC DRAINABLE POUCH HIGH OUTPUT W/FILTER
Type of Device
POUCH, COLOSTOMY
Manufacturer (Section D)
CONVATEC DOMINICAN REPUBLIC, INC.
carretera sanchez, km. 18.5, parque industrial
haina, san cristobal 3310 2
DR  33102
Manufacturer Contact
matthew walenciak, director
211 american ave.
greensboro, NC 27409
9083779293
MDR Report Key4138060
MDR Text Key19762051
Report Number9618003-2014-11199
Device Sequence Number1
Product Code EZQ
Combination Product (y/n)N
Reporter Country CodeJA
PMA/PMN Number
K780454
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Company Representative,Distributor
Reporter Occupation Not Applicable
Type of Report Initial
Report Date 12/19/2012
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other
Device Expiration Date05/01/2017
Device Model Number401557
Device Lot Number2D02551
Was Device Available for Evaluation? No
Initial Date Manufacturer Received 12/19/2012
Initial Date FDA Received09/29/2014
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured05/01/2012
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unknown
Patient Sequence Number1
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