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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CONVATEC INC L3O0675 - ESTEEM+ I

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CONVATEC INC L3O0675 - ESTEEM+ I Back to Search Results
Model Number 421626
Device Problem Sharp Edges (4013)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Type  malfunction  
Manufacturer Narrative
Device 5 of 7. Common device name: pouch, colostomy. Contact office address: (b)(4). Based on the available information, this event is deemed to be a reportable malfunction. 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's wife reported that the edge of the opening was rough instead of smooth in 7 out of 10 appliances. The product was not used on patient. Photograph depicting the issue was received from the complainant.
 
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Brand NameL3O0675 - ESTEEM+
Type of DeviceI
Manufacturer (Section D)
CONVATEC INC
211 american avenue
greensboro NC
Manufacturer (Section G)
CONVATEC INC
211 american avenue
greensboro NC
Manufacturer Contact
pamela meadows
7815 national service road
suite 600
greensboro, NC 
3365424679
MDR Report Key12365047
MDR Text Key268049649
Report Number1049092-2021-00088
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 other
Reporter Occupation
Type of Report Initial
Report Date 07/30/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received08/25/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number421626
Device Lot Number0000252523
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 Received07/30/2021
Was Device Evaluated by Manufacturer? No
Date Device Manufactured02/28/2020
Is the Device Single Use? No Answer Provided
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unkown

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