WOUND CARE-UNKNOWN SURGICAL COVER DRESSI

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 2019-07-02 for WOUND CARE-UNKNOWN SURGICAL COVER DRESSI manufactured by Convatec Dominican Republic Inc.

MAUDE Entry Details

Report Number9618003-2019-04625
MDR Report Key8754032
Report SourceCONSUMER
Date Received2019-07-02
Date Mfgr Received2019-06-19
Date Added to Maude2019-07-02
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 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

Generic NameDRESSING, WOUND, HYDROPHILIC
Product CodeNAC
Date Received2019-07-02
Model NumberWOUND CARE-UNKNOWN SURGICAL COVER DRESSI
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device Eval'ed by MfgrN
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 2019-07-02

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