ESTEEM SYNERGY 403986

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a distributor,foreign report with the FDA on 2018-06-08 for ESTEEM SYNERGY 403986 manufactured by Convatec Dominican Republic Inc.

Event Text Entries

[110578613] (b)(6). Based on the available information, this event is deemed to be a reportable malfunction. 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).
Patient Sequence No: 1, Text Type: N, H10


[110578615] The distributor reported the skin barrier starter hole was defective (off center). The device was not used. No further information or photograph was provided.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number9618003-2018-00386
MDR Report Key7584267
Report SourceDISTRIBUTOR,FOREIGN
Date Received2018-06-08
Date Mfgr Received2018-05-15
Date Added to Maude2018-06-08
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 G1CONVATEC DOMINICAN REPUBLIC INC
Manufacturer StreetKM 18.5 PARQUE INDUSTRIAL ITABO, S.A. HAINA
Manufacturer CitySAN CRISTOBAL
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameESTEEM SYNERGY
Generic NameAPPLIANCE, COLOSTOMY, DISPOSABLE
Product CodeEZS
Date Received2018-06-08
Model Number403986
Device AvailabilityN
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerCONVATEC DOMINICAN REPUBLIC INC
Manufacturer AddressKM 18.5 PARQUE INDUSTRIAL ITABO, S.A. HAINA SAN CRISTOBAL


Patients

Patient NumberTreatmentOutcomeDate
10 2018-06-08

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