MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a * report with the FDA on 2015-03-10 for SEGAWE DIAMOND DERMABRASION MICRODERMABRASION MACHINE manufactured by Segawe.
[5483973]
(b)(4). I am actually reporting a diamond microdermabrasion machine which is not on your list but it is considered class 1 exempt - however this machine does not have a device listing which is required by the fda - i tried to use this for the first time and it left several bleeding scratches on my skin - it is very dangerous chinese and they are not using save and approved abrasives. This machine came from a company "segawe" selling out of a (b)(4) warehouse " - usa. They are selling 1000's of these dangerous machines online.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5041367 |
| MDR Report Key | 4587345 |
| Report Source | * |
| Date Received | 2015-03-10 |
| Date of Report | 2015-02-06 |
| Date of Event | 2015-02-01 |
| Date Added to Maude | 2015-03-10 |
| 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 | 0 |
| Reporter Occupation | PATIENT |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Single Use | 0 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | SEGAWE DIAMOND DERMABRASION MICRODERMABRASION MACHINE |
| Product Code | GFE |
| Date Received | 2015-03-10 |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | SEGAWE |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Life Threatening; 2. Deathisabilit | 2015-03-10 |