ALDOM ASIN: B078JLD3S1 UPC: 6142512542

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-06-01 for ALDOM ASIN: B078JLD3S1 UPC: 6142512542 manufactured by Aldom.

Event Text Entries

[110072097] This product sold on amazon is featuring the fda logo, implying it is endorsed by the administration: https://www. Amazon. Com/aldom-blackhead-remover-vacuum-microdermabrasion/dp/b078jld3s1/ref=zg_bs_13861656011_1? _encoding=utf8&psc=1&refrid=rjxt1hdy61g553k3e4v. Blackhead remover poor vacuum.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report NumberMW5077609
MDR Report Key7565012
Date Received2018-06-01
Date of Report2018-05-31
Date of Event2018-05-31
Date Added to Maude2018-06-04
Event Key0
Report Source CodeVoluntary report
Manufacturer LinkN
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Reporter OccupationPATIENT
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Single Use3
Previous Use Code3
Event Type3
Type of Report0

Device Details

Brand NameALDOM
Generic NameMICRODERMABRASION MACHINE
Product CodeGFE
Date Received2018-06-01
Model NumberASIN: B078JLD3S1 UPC: 6142512542
Device AvailabilityN
Device Eval'ed by MfgrI
Device Sequence No1
Device Event Key0
ManufacturerALDOM


Patients

Patient NumberTreatmentOutcomeDate
10 2018-06-01

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