ALDAHOL

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 2019-09-25 for ALDAHOL manufactured by Dfb Technology, Ltd..

MAUDE Entry Details

Report Number3003690398-2019-00004
MDR Report Key9121494
Report SourceHEALTH PROFESSIONAL,USER FACI
Date Received2019-09-25
Date of Report2019-09-25
Date of Event2019-07-30
Date Mfgr Received2019-08-05
Device Manufacturer Date2019-04-01
Date Added to Maude2019-09-25
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Reporter OccupationOTHER HEALTH CARE PROFESSIONAL
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Manufacturer ContactMR. MARK MITCHELL
Manufacturer Street3909 HULEN ST
Manufacturer CityFORT WORTH TX 76107
Manufacturer CountryUS
Manufacturer Postal76107
Manufacturer Phone8179004074
Manufacturer G1ALDEN MEDICAL LLC
Manufacturer Street360 COLD SPRING AVENUE
Manufacturer CityWEST SPRINGFIELD MA 01089
Manufacturer CountryUS
Manufacturer Postal Code01089
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameALDAHOL
Generic NameHIGH LEVEL DISINFECTANT
Product CodeMED
Date Received2019-09-25
Lot Number191947
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerDFB TECHNOLOGY, LTD.
Manufacturer Address3909 HULEN ST FORT WORTH 76107 US 76107


Patients

Patient NumberTreatmentOutcomeDate
101. Hospitalization 2019-09-25

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