MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2020-02-12 for SKIN CLASSIC manufactured by Clareblend, Inc..
[179451588]
While getting a facial my daughter was offered a "new" treatment for her black/heads on her chin. The treatment burnt all the pores on her chin causing severe pain, scarring and ice pick deep scars. Burned chin scaring pain. "rnfaces". Fda safety report id# (b)(4).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5092983 |
| MDR Report Key | 9706617 |
| Date Received | 2020-02-12 |
| Date of Report | 2020-02-09 |
| Date of Event | 2019-12-20 |
| Date Added to Maude | 2020-02-13 |
| 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 FAMILY MEMBER OR FRIEND |
| 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 | 3 |
| Brand Name | SKIN CLASSIC |
| Generic Name | EPILATOR HIGH FREQUENCY NEEDLE-TYPE |
| Product Code | KCW |
| Date Received | 2020-02-12 |
| Device Availability | N |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | CLAREBLEND, INC. |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2020-02-12 |