MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-02-13 for STRAWBERRY LASER manufactured by Unk.
[100246397]
(b)(6) operating as (b)(6) is operating an fda medical device and is not a doctor, nor does she have a medical doctor on premises. They are operating out of (b)(6). They have since changed their website and their literature to say that they are a medspa which they are not. I did not feel well after my initial visit. My stomach hurt and cramped and i had red marks on my stomach. When i asked to speak to the physician, i was told there is no physician that she is a certified laser technician.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5075229 |
| MDR Report Key | 7269606 |
| Date Received | 2018-02-13 |
| Date of Report | 2018-02-10 |
| Date of Event | 2018-01-09 |
| Date Added to Maude | 2018-02-14 |
| 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 | STRAWBERRY LASER |
| Generic Name | STRAWBERRY LASER |
| Product Code | OLI |
| Date Received | 2018-02-13 |
| Device Availability | N |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | UNK |
| Manufacturer Address | UNK UNK |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2018-02-13 |