AQUACEL/AQUACEL AG - ANTIMICROBIAL AG HYDROFIBER DRESSING ROPE 403771

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 2020-01-24 for AQUACEL/AQUACEL AG - ANTIMICROBIAL AG HYDROFIBER DRESSING ROPE 403771 manufactured by Convatec Ltd.

MAUDE Entry Details

Report Number1000317571-2020-00002
MDR Report Key9628900
Report SourceHEALTH PROFESSIONAL,USER FACI
Date Received2020-01-24
Date of Event2020-01-21
Date Mfgr Received2020-01-22
Date Added to Maude2020-01-24
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 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 - ANTIMICROBIAL AG HYDROFIBER DRESSING ROPE
Generic NameDRESSING, WOUND, DRUG
Product CodeFRO
Date Received2020-01-24
Model Number403771
Catalog Number403771
Lot Number9J02334
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 2020-01-24

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