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.
[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
Report Number | MW5077609 |
MDR Report Key | 7565012 |
Date Received | 2018-06-01 |
Date of Report | 2018-05-31 |
Date of Event | 2018-05-31 |
Date Added to Maude | 2018-06-04 |
Event Key | 0 |
Report Source Code | Voluntary report |
Manufacturer Link | N |
Number of Patients in Event | 0 |
Adverse Event Flag | 3 |
Product Problem Flag | 3 |
Reprocessed and Reused Flag | 3 |
Reporter Occupation | PATIENT |
Health Professional | 3 |
Initial Report to FDA | 3 |
Report to FDA | 3 |
Event Location | 3 |
Single Use | 3 |
Previous Use Code | 3 |
Event Type | 3 |
Type of Report | 0 |
Brand Name | ALDOM |
Generic Name | MICRODERMABRASION MACHINE |
Product Code | GFE |
Date Received | 2018-06-01 |
Model Number | ASIN: B078JLD3S1 UPC: 6142512542 |
Device Availability | N |
Device Eval'ed by Mfgr | I |
Device Sequence No | 1 |
Device Event Key | 0 |
Manufacturer | ALDOM |
Patient Number | Treatment | Outcome | Date |
---|---|---|---|
1 | 0 | 2018-06-01 |