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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CONVATEC DOMINICAN REPUBLIC INC ESTEEM + POUCH, COLOSTOMY

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CONVATEC DOMINICAN REPUBLIC INC ESTEEM + POUCH, COLOSTOMY Back to Search Results
Model Number 416719
Device Problem Sharp Edges (4013)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Type  malfunction  
Manufacturer Narrative
Based on the available information, this event is deemed to be a reportable malfunction. This complaint has been evaluated. No lot number is available. A detailed investigation or batch review cannot be conducted. Therefore, this evaluation will be closed. This issue will be monitored through the post market product monitoring review process. To date no additional information has been received. Should additional information become available, a follow-up report will be submitted. (b)(4).
 
Event Description
The end user stated that the adhesive on the product broke down after getting wet with daily showering and became hard, sharp and brittle. He had to change pouch every 2 days. Reportedly, he washed his skin with unknown soap and water.
 
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Brand NameESTEEM +
Type of DevicePOUCH, COLOSTOMY
Manufacturer (Section D)
CONVATEC DOMINICAN REPUBLIC INC
km 18.5 parque industrial
itabo, s.a. haina
san cristobal
Manufacturer (Section G)
CONVATEC DOMINICAN REPUBLIC INC
km 18.5 parque industrial
itabo, s.a. haina
san cristobal
Manufacturer Contact
jeanette johnson
7900 triad center drive
suite 400
greensboro, NC 27409
3365424681
MDR Report Key9259766
MDR Text Key164403050
Report Number9618003-2019-05749
Device Sequence Number1
Product Code EZQ
Combination Product (y/n)N
PMA/PMN Number
EXEMPT
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type consumer
Reporter Occupation
Type of Report Initial
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received10/31/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? No
Device Operator
Device Model Number416719
Was Device Available for Evaluation? No
Is the Reporter a Health Professional?
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received10/08/2019
Was Device Evaluated by Manufacturer? No
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

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