SAALT REGULAR BLUE

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 2020-02-18 for SAALT REGULAR BLUE manufactured by Saalt, Llc.

MAUDE Entry Details

Report Number3014276660-2020-20054
MDR Report Key9720795
Report SourceCONSUMER
Date Received2020-02-18
Date of Report2020-02-13
Date of Event2020-01-06
Date Mfgr Received2020-01-06
Date Added to Maude2020-02-18
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 ContactDANIELLE BURDEN
Manufacturer Street6149 N. MEEKER PLACE STE. 110
Manufacturer CityBOISE, ID
Manufacturer CountryUS
Manufacturer Phone3682646
Single Use3
Remedial ActionRL
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameSAALT
Generic NameREGULAR BLUE
Product CodeHHE
Date Received2020-02-18
Model NumberREGULAR BLUE
OperatorLAY USER/PATIENT
Device AvailabilityN
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerSAALT, LLC
Manufacturer Address6149 N. MEEKER PLACE STE. 110 BOISE, ID US


Patients

Patient NumberTreatmentOutcomeDate
101. Required No Informationntervention 2020-02-18

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