MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,07,08 report with the FDA on 2015-05-29 for EMBOSPHERE JICROSPHERES UNK manufactured by Biosphere Medical, S.a..
[15368964]
Nothing is expected to be returned for evaluation. Since the lot number was not provided, the device history record could not be reviewed for this lot. However complaint database was reviewed for similar issues, and no similar event was found. Merit medical/biosphere medical will continue to pay attention to the development of similar events.
Patient Sequence No: 1, Text Type: N, H10
[15391435]
Primary disease: neuroendocrine tumour with metastasis to the liver. About 3 days after embolisation with the device, c-reactive protein level increased and slight fever was developed. Computed tomography was performed, showing liver abscess. Symptoms were developed about 3 days after the use of embosphere, so liver abscess was considered to be related to the device.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9615728-2015-00006 |
| MDR Report Key | 4808043 |
| Report Source | 01,07,08 |
| Date Received | 2015-05-29 |
| Date of Report | 2015-05-01 |
| Date of Event | 2015-02-27 |
| Date Mfgr Received | 2015-05-01 |
| Date Added to Maude | 2015-06-02 |
| 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 | PARC DES NATIONA - PARIS NORD 2 383, RUE DE LA BELLE ETOILE |
| Manufacturer City | ROSSY 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 JICROSPHERES |
| Product Code | NAJ |
| Date Received | 2015-05-29 |
| Model Number | UNK |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BIOSPHERE MEDICAL, S.A. |
| Manufacturer Address | ROSSY-EN-FRANCE FR |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization; 2. Other | 2015-05-29 |