MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-03-29 for BOSIDIN FACIAL & BODY PERMANENT HAIR REMOVAL FOR WOMEN manufactured by Bosidi Technology, Co., Ltd..
[140603930]
I tried to use the product that i bought from (b)(6). The link is (b)(6). However, after i used this device on my face, it felt very painful and my neck was burned up. When we tried to search fda info about this device, there is nothing. Is this product fda approved? The device was bought from (b)(6).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5085427 |
| MDR Report Key | 8470770 |
| Date Received | 2019-03-29 |
| Date of Report | 2019-03-26 |
| Date of Event | 2019-02-16 |
| Date Added to Maude | 2019-04-01 |
| 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 | BOSIDIN FACIAL & BODY PERMANENT HAIR REMOVAL FOR WOMEN |
| Generic Name | LIGHT BASED OVER-THE-COUNTER HAIR REMOVAL |
| Product Code | OHT |
| Date Received | 2019-03-29 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BOSIDI TECHNOLOGY, CO., LTD. |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2019-03-29 |