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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CONVATEC DOMINICAN REPUBLIC INC L3O0675 - ESTEEM+ POUCH, COLOSTOMY

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CONVATEC DOMINICAN REPUBLIC INC L3O0675 - ESTEEM+ POUCH, COLOSTOMY Back to Search Results
Model Number 416737
Device Problems Material Deformation (2976); Sharp Edges (4013)
Patient Problem No Patient Involvement (2645)
Event Date 01/13/2021
Event Type  malfunction  
Manufacturer Narrative
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
It was reported that in 1 out of sample pack of 3 appliances, the starter hole was jagged and where it was jagged, the mass felt uneven/rippled on the non-skin side of the mass. The product was not used on patient. A photograph depicting the issue was received from the complainant.
 
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Brand NameL3O0675 - ESTEEM+
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
pamela meadows
7815 national service road
suite 600
greensboro, NC 27409
3365424679
MDR Report Key11284628
MDR Text Key230450189
Report Number9618003-2021-00174
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 company representative
Reporter Occupation
Type of Report Initial,Followup
Report Date 01/13/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received02/05/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other
Device Model Number416737
Device Lot Number9J00533
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? Yes
Event Location No Information
Date Manufacturer Received09/02/2021
Was Device Evaluated by Manufacturer? No
Date Device Manufactured09/10/2019
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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