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 2017-05-31 for EMBOZENE? MICROSPHERES 01-0301-07002-04 17020-S1 manufactured by .
[76395621]
(b)(4). Device evaluation by manufacturer: it is indicated that the device will not be returned for evaluation; therefore a failure analysis of the complaint device could not be completed. The most probable root cause was unable to be determined. (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[76395622]
It was reported that the device package sterility was compromised. An embozene? Microspheres package was selected to prep for a procedure. It was noted that the packaging seal was not fully closed. The device was not used for the procedure and the procedure was completed with another embozene?.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2134265-2017-05269 |
| MDR Report Key | 6603368 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2017-05-31 |
| Date of Report | 2017-05-10 |
| Date of Event | 2017-05-10 |
| Date Mfgr Received | 2017-05-10 |
| Date Added to Maude | 2017-05-31 |
| 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 | 2017-05-31 |
| Model Number | 01-0301-07002-04 |
| Catalog Number | 17020-S1 |
| Lot Number | 1703011AAA |
| 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 | 2017-05-31 |