AQUACEL/AQUACEL AG - SURGICAL COVER DRESSINGS 412011

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional,user faci report with the FDA on 2019-11-20 for AQUACEL/AQUACEL AG - SURGICAL COVER DRESSINGS 412011 manufactured by Convatec Dominican Republic Inc.

MAUDE Entry Details

Report Number9618003-2019-06046
MDR Report Key9351011
Report SourceHEALTH PROFESSIONAL,USER FACI
Date Received2019-11-20
Date of Event2019-10-11
Date Mfgr Received2019-10-23
Date Added to Maude2019-11-20
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

Brand NameAQUACEL/AQUACEL AG - SURGICAL COVER DRESSINGS
Generic NameDRESSING, WOUND, DRUG
Product CodeFRO
Date Received2019-11-20
Model Number412011
Catalog Number412011
Lot Number7L06482
Device Expiration Date2019-12-01
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 2019-11-20

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