MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2015-03-05 for UTERINE ARTERY EMOBLIZATION manufactured by .
[17945147]
One month after (b)(6) patient felt extreme pelvic pain, worst pain ever experienced. Required high dose morphine and heating pads to reduce pain. High fevers, chills the first five days. Contracted a bacterial infection for 2-4 weeks after uae. She had a thick, foul smelling discharge followed by the passing of necrotic fibroid. Immediate relief of pain followed. Eight months post uae she stopped having pain, discharge and menstrual periods. Since then she has had no sex drive, extreme vaginal dryness and painful sexual intercourse. She has very low estrogen levels and menopausal symptoms.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5041371 |
| MDR Report Key | 4603110 |
| Date Received | 2015-03-05 |
| Date of Report | 2015-03-05 |
| Date of Event | 2006-08-26 |
| Date Added to Maude | 2015-03-17 |
| 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 | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| 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 | NI |
| Generic Name | UTERINE ARTERY EMOBLIZATION |
| Product Code | NAJ |
| Date Received | 2015-03-05 |
| Operator | HEALTH PROFESSIONAL |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Deathisabilit | 2015-03-05 |