MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-12-26 for BTL ULTRAFEMME 360 manufactured by Btl Industries, Inc..
[131620673]
I am (b)(6) and i do not speak english well, so i am trying to explain the problem. A (b)(6) gynecologist recommended to me to use the use of radiofrequency btl ultrafemme 360 inside my vagina to improve my sexual relations. 24 hours after the first session, i started to feel a chronic pain in my belly like permanent muscle contractions. The gynecologist does not know what is happening to me.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5082613 |
| MDR Report Key | 8199563 |
| Date Received | 2018-12-26 |
| Date of Report | 2018-12-24 |
| Date of Event | 2018-09-17 |
| Date Added to Maude | 2018-12-27 |
| 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 | BTL ULTRAFEMME 360 |
| Generic Name | MASSAGER, VACUUM, LIGHT INDUCED HEATING |
| Product Code | NUV |
| Date Received | 2018-12-26 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BTL INDUSTRIES, INC. |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Deathisabilit | 2018-12-26 |