AQUACEL/AQUACEL AG - SURGICAL COVER DRESSINGS 412019

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign,health professional,u report with the FDA on 2019-07-31 for AQUACEL/AQUACEL AG - SURGICAL COVER DRESSINGS 412019 manufactured by Convatec Ltd.

MAUDE Entry Details

Report Number1000317571-2019-00089
MDR Report Key8847484
Report SourceFOREIGN,HEALTH PROFESSIONAL,U
Date Received2019-07-31
Date of Event2019-07-14
Date Mfgr Received2019-07-22
Date Added to Maude2019-07-31
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 LTD
Manufacturer StreetFIRST AVENUE DEESIDE INDUSTRIAL PARK
Manufacturer CityDEESIDE, FLINTSHIRE CH5 2NU
Manufacturer CountryUK
Manufacturer Postal CodeCH5 2NU
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameAQUACEL/AQUACEL AG - SURGICAL COVER DRESSINGS
Generic NameDRESSING,WOUND,HYDROPHILIC
Product CodeNAC
Date Received2019-07-31
Model Number412019
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device Eval'ed by MfgrN
Device Sequence No1
Device Event Key0
ManufacturerCONVATEC LTD
Manufacturer AddressFIRST AVENUE DEESIDE INDUSTRIAL PARK DEESIDE, FLINTSHIRE CH5 2NU UK CH5 2NU


Patients

Patient NumberTreatmentOutcomeDate
10 2019-07-31

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