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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CONVATEC INC. SUR-FIT AUTOLOCK UROSTOMY POUCH W/ACCUSEAL TAP; URINARY, ILEOSTOMY
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CONVATEC INC. SUR-FIT AUTOLOCK UROSTOMY POUCH W/ACCUSEAL TAP; URINARY, ILEOSTOMY Back to Search Results
Model Number 401453
Device Problem Device Operates Differently Than Expected (2913)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 10/13/2013
Event Type  malfunction  
Event Description
Reporter states the pouch ring is sewn above the normal area making the anti-reflex valve unfunctional.
 
Manufacturer Narrative
Based on the available information, this event is deemed a reportable malfunction.No additional patient/event details have been provided to date.A return sample for evaluation is not expected.Should additional information become available, a follow-up report will be submitted.Reported to the fda on january 14, 2014.
 
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Brand Name
SUR-FIT AUTOLOCK UROSTOMY POUCH W/ACCUSEAL TAP
Type of Device
URINARY, ILEOSTOMY
Manufacturer (Section D)
CONVATEC INC.
carretera sanchez, km. 18.5
parque industrial itabo, s.a.
san cristobal, haina
DR 
Manufacturer Contact
mary szaro, assoc dir
200 headquarters park drive
skillman, NJ 08558
9089042450
MDR Report Key3783125
MDR Text Key4439543
Report Number9618003-2014-00010
Device Sequence Number1
Product Code EXB
Combination Product (y/n)N
Reporter Country CodePO
PMA/PMN Number
K840166
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Consumer,Company Representative
Reporter Occupation Not Applicable
Type of Report Initial
Report Date 11/05/2013
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 Lay User/Patient
Device Expiration Date03/23/2018
Device Model Number401453
Device Catalogue Number401453
Device Lot Number3C01390
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Initial Date Manufacturer Received 11/05/2013
Initial Date FDA Received01/15/2014
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured03/01/2013
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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