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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CONVATEC INC ESTEEM+ FLEX CONVEX; POUCH, COLOSTOMY

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CONVATEC INC ESTEEM+ FLEX CONVEX; POUCH, COLOSTOMY Back to Search Results
Model Number 421620
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 reported that in an unknown quantity of products, the starter hole 'was cut very jagged'.Normally it had to be cut to the size of the stoma.The one he received looked as though someone had just taken a pair of dull scissors and hand cut the opening.The end user used a razor blade to smoothen this out.It was unknown whether he used the product.There was no harm reported.No photo is available at this time.
 
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Brand Name
ESTEEM+ FLEX CONVEX
Type of Device
POUCH, COLOSTOMY
Manufacturer (Section D)
CONVATEC INC
211 american avenue
greensboro NC 27409
Manufacturer (Section G)
CONVATEC INC
211 american avenue
greensboro NC 27409
Manufacturer Contact
jeanette johnson
7900 triad center drive
suite 400
greensboro, NC 27409
3365424681
MDR Report Key9871225
MDR Text Key204626234
Report Number1049092-2020-00110
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 Other
Type of Report Initial
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? No
Device Operator Lay User/Patient
Device Model Number421620
Was Device Available for Evaluation? No
Was the Report Sent to FDA? No
Initial Date Manufacturer Received 03/02/2020
Initial Date FDA Received03/24/2020
Was Device Evaluated by Manufacturer? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage N
Patient Sequence Number1
Patient Age65
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