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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CONVATEC DOMINICAN REPUBLIC, INC. ESTEEM + DRAINABLE POUCH EXTENDED WEAR (64MM)

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CONVATEC DOMINICAN REPUBLIC, INC. ESTEEM + DRAINABLE POUCH EXTENDED WEAR (64MM) Back to Search Results
Model Number 416976
Device Problem Leak/Splash (1354)
Patient Problem Skin Irritation (2076)
Event Type  Injury  
Event Description
It was reported the end user developed skin irritation beneath the skin barrier due to leakage from the stoma.The end user indicated her stoma is positioned within a deep crease in her abdomen which has resulted in stoma leakage.The end user sought treatment from a physician and was issued a prescription for nystatin powder.No further patient consequences were reported.
 
Manufacturer Narrative
Based on the available information, this event is deemed to be a serious injury.No additional patient/event details have been provided to date.Should additional information become available, a follow-up report will be submitted.
 
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Brand Name
ESTEEM + DRAINABLE POUCH EXTENDED WEAR (64MM)
Manufacturer (Section D)
CONVATEC DOMINICAN REPUBLIC, INC.
carretera sanchez, km. 18.2
parque industrial itabo, s.a.
san cristobal, haina 3310 2
DR  33102
Manufacturer Contact
matthew walenciak, director
211 american ave.
greensboro, NC 27409
9083779293
MDR Report Key4948762
MDR Text Key6640666
Report Number9618003-2015-00038
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 Consumer
Reporter Occupation Not Applicable
Type of Report Initial
Report Date 07/09/2015
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 Number416976
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Initial Date Manufacturer Received 07/09/2015
Initial Date FDA Received07/27/2015
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 Initial
Patient Sequence Number1
Treatment
LIPITOR
Patient Outcome(s) Required Intervention;
Patient Weight62
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