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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CONVATEC DOMINICAN REPUBLIC, INC. ESTEEM ONE-PIECE CUT-TO-FIT CLOSED-END POUCH; POUCH, COLOSTOMY

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CONVATEC DOMINICAN REPUBLIC, INC. ESTEEM ONE-PIECE CUT-TO-FIT CLOSED-END POUCH; POUCH, COLOSTOMY Back to Search Results
Model Number 416700
Device Problem Difficult to Remove (1528)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Type  malfunction  
Manufacturer Narrative
Based on the available information, this event is deemed a reportable malfunction.There were no reports of the patient being harmed as a result of this malfunction.No further information was available at the time of the report.Should additional information become available, a follow-up report will be submitted.
 
Event Description
It was reported that within 24 hours of use, the end user had difficulty removing the wafer.According to the end user, "the mass is strongly adhered and when she tries to remove it the mass shreds into strings.".
 
Manufacturer Narrative
A batch record review indicates no discrepancies.No physical sample or photograph is expected.The product was manufactured under the appropriate device specification.The crew requirements and responsibilities, process parameters, quality and in-process inspections, line operations, process troubleshooting and relevant documents to the process were run according to the appropriate process instructions.The process requirements results were documented in the product batch record.The product was packed and labeled under the appropriate packaging and labeling specification.No non-conformances, deviations or discrepancies were found during revision.No further action is required and this issue will be monitored through the post market product monitoring review process.No additional patient/event details have been provided to date.Should additional information become available a follow-up report will be submitted.(b)(4).
 
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Brand Name
ESTEEM ONE-PIECE CUT-TO-FIT CLOSED-END POUCH
Type of Device
POUCH, COLOSTOMY
Manufacturer (Section D)
CONVATEC DOMINICAN REPUBLIC, INC.
carretera sanchez, km 18.5
parque industrial itabo, s.a.
haina, san cristobal 33102
DR  33102
Manufacturer Contact
jeanette johnson
7900 triad center drive
suite 400
greensboro, NC 27409
3365424681
MDR Report Key5588665
MDR Text Key43190417
Report Number9618003-2016-00017
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 Patient
Type of Report Initial,Followup
Report Date 03/29/2016
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 Date07/10/2019
Device Model Number416700
Device Lot Number4G00843
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Initial Date Manufacturer Received 03/29/2016
Initial Date FDA Received04/20/2016
Supplement Dates Manufacturer ReceivedNot provided
Supplement Dates FDA Received06/22/2016
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured07/11/2014
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Patient Age77 YR
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