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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CONVATEC INC. ESTEEM 1 PC CLOSED END POUCH - APS; POUCH, COLOSTOMY

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CONVATEC INC. ESTEEM 1 PC CLOSED END POUCH - APS; POUCH, COLOSTOMY Back to Search Results
Model Number 416715
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Skin Discoloration (2074)
Event Date 08/15/2014
Event Type  Injury  
Event Description
It is reported the end user developed redness under portion of the one piece closed end pouch mass.End user reports going to the emergency room on (b)(6) 2014 due to the redness and was given tramadol 50mg tablets for pain.
 
Manufacturer Narrative
Based on the available information, this event is deemed to be a serious injury.End user reports using the closed end device for 8 days with daily changing.She had used modified stomahesive mass previously without redness.She also reports using smith and nephew protectant wipe in combination, and uses just water to rinse skin.She reports pain was a 3 on a scale of 1-10 reports peristomal area was cleansed but no ointment or cream applied.No other prescription or over the counter medications were provided.She reports emergency room md thought it might be allergic reaction.She reports redness is better today and no pain currently.Reports had migraine headache last evening also.Reports she was instructed by emergency room to go back to her drainable convatec pouch.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.
 
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Brand Name
ESTEEM 1 PC CLOSED END POUCH - APS
Type of Device
POUCH, COLOSTOMY
Manufacturer (Section D)
CONVATEC INC.
carretera sanchez, km. 18.5
parque industrial itabo, s.a.
san cristobal, haina
DR 
Manufacturer Contact
matthew walenciak, director
211 american avenue
greensboro, NC 27409
9083779293
MDR Report Key4098094
MDR Text Key20857620
Report Number9618003-2014-00081
Device Sequence Number1
Product Code EZQ
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
EXEMPT
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Health Professional,User Facility,Company Representative
Reporter Occupation Not Applicable
Type of Report Initial
Report Date 08/15/2014
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Lay User/Patient
Device Model Number416715
Device Catalogue Number416715
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Initial Date Manufacturer Received 08/15/2014
Initial Date FDA Received09/03/2014
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unknown
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
Patient Weight49
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