MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2015-02-06 for PRO 3-1 MINI DIAMOND MICRODERMABRASION manufactured by .
[5534552]
I am reporting a diamond microdermabrasion machine which is considered class 1 (exempt) - however this machine does not have a device listing which is required by the fda - i ordered from online and i tried to use this for the first time and it left several bleeding scratches on my skin - it is very dangerous; (b)(6) are not using safe and approved abrasives. This machine came from a company "(b)(4)" selling out of a (b)(4) warehouse "(b)(4). They are selling 1000's of these dangerous machines online. Also, this machine has multiple functions like sprayers, tanner, ultrasound, and others that are not allowed under the class 1 designation and many of these other functions seem like they should require fda clearance like ultrasound.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5040702 |
| MDR Report Key | 4516244 |
| Date Received | 2015-02-06 |
| Date of Report | 2015-02-06 |
| Date of Event | 2015-02-01 |
| Date Added to Maude | 2015-02-18 |
| 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 | 0 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | PRO 3-1 MINI DIAMOND MICRODERMABRASION |
| Generic Name | DERMABRASION FACIAL PEEL MACHINE |
| Product Code | GFE |
| Date Received | 2015-02-06 |
| Operator | OTHER |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2015-02-06 |