MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 00,01,07,08 report with the FDA on 2015-01-14 for EMBOSPHERE MICROSPHERES S620GH S620G manufactured by Biosphere Medical, S.a..
[5347759]
The distributor reported that a fiber/hair was identified in the barrel of the syringe during their 100% inspection of received product. The device was not sent to a user facility.
Patient Sequence No: 1, Text Type: D, B5
[12940587]
Device returned to mfr for eval. The eval is in progress. A f/u report will be submitted when the eval is completed.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 9615728-2015-00002 |
| MDR Report Key | 4479671 |
| Report Source | 00,01,07,08 |
| Date Received | 2015-01-14 |
| Date of Report | 2014-12-25 |
| Date of Event | 2014-11-26 |
| Date Mfgr Received | 2014-12-25 |
| Device Manufacturer Date | 2014-10-01 |
| Date Added to Maude | 2015-03-02 |
| 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 | 0 |
| Event Location | 0 |
| Manufacturer Contact | ALIX FONLLADOSA |
| Manufacturer Street | 383, RUE DE LA BELLE ETOILE PARC DES NATIONS - PARIS NORD 2 |
| Manufacturer City | ROISSY EN FRANCE 95 700 |
| Manufacturer Country | FR |
| Manufacturer Postal | 95 700 |
| Manufacturer Phone | 4817252 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | EMBOSPHERE MICROSPHERES |
| Generic Name | AGENTS, EMBOLIC, FOR TREATMENT OF UF |
| Product Code | NAJ |
| Date Received | 2015-01-14 |
| Returned To Mfg | 2014-12-30 |
| Model Number | S620GH |
| Catalog Number | S620G |
| Lot Number | X710163 |
| Device Expiration Date | 2017-09-30 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BIOSPHERE MEDICAL, S.A. |
| Manufacturer Address | ROISSY-EN-FRANCE FR |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2015-01-14 |