ESTEEM+ FLEX CONVEX 421620

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a consumer report with the FDA on 2020-03-24 for ESTEEM+ FLEX CONVEX 421620 manufactured by Convatec Inc.

MAUDE Entry Details

Report Number1049092-2020-00110
MDR Report Key9871225
Report SourceCONSUMER
Date Received2020-03-24
Date Mfgr Received2020-03-02
Date Added to Maude2020-03-24
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Manufacturer ContactMS. JEANETTE JOHNSON
Manufacturer Street7900 TRIAD CENTER DRIVE SUITE 400
Manufacturer CityGREENSBORO NC 27409
Manufacturer CountryUS
Manufacturer Postal27409
Manufacturer Phone3365424681
Manufacturer G1CONVATEC INC
Manufacturer Street211 AMERICAN AVENUE
Manufacturer CityGREENSBORO NC 27409
Manufacturer CountryUS
Manufacturer Postal Code27409
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameESTEEM+ FLEX CONVEX
Generic NamePOUCH, COLOSTOMY
Product CodeEZQ
Date Received2020-03-24
Model Number421620
OperatorLAY USER/PATIENT
Device AvailabilityN
Device Eval'ed by MfgrN
Device Sequence No1
Device Event Key0
ManufacturerCONVATEC INC
Manufacturer Address211 AMERICAN AVENUE GREENSBORO NC 27409 US 27409


Patients

Patient NumberTreatmentOutcomeDate
10 2020-03-24

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