MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,health report with the FDA on 2017-03-29 for EMBOZENE? MICROSPHERES UNK939 manufactured by .
[71163383]
Manufacturer name and manufacturer site name: celonova biosciences (b)(4). Device evaluated by mfr: the complaint device was not returned for analysis. The batch number is unknown and the manufacturing records for the complaint device could not be reviewed. The most probable root cause was unable to be determined.
Patient Sequence No: 1, Text Type: N, H10
[71163385]
It was reported that a patient who had underwent a uterine fibroid embolization (ufe) procedure involving embozene? Microspheres experienced symptoms of body tingling and heart palpitations starting a week after the ufe. In addition, the patient experienced sloughing of skin from her palms and soles of her feet 2-3 weeks after the ufe, which has since healed. Cardiac workups were performed which were negative.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2134265-2017-02511 |
| MDR Report Key | 6443182 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2017-03-29 |
| Date of Report | 2017-03-03 |
| Date Mfgr Received | 2017-03-03 |
| Date Added to Maude | 2017-03-29 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | EMP. SONALI ARANGIL |
| Manufacturer Street | ONE SCIMED PLACE |
| Manufacturer City | MAPLE GROVE MN 55311 |
| Manufacturer Country | US |
| Manufacturer Postal | 55311 |
| Manufacturer Phone | 7634941700 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | EMBOZENE? MICROSPHERES |
| Generic Name | EMBOLIC DEVICE |
| Product Code | NAJ |
| Date Received | 2017-03-29 |
| Model Number | UNK939 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2017-03-29 |