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 MICROSPHERES UNK manufactured by Biosphere Medical, S.a..
[15916226]
The patient was treated for hepatic cancer using emoblics. On an unknown date, postoperative cholecystitis developed and was treated surgically. The cause of the cholecystitis could not be identified. No detailed information was available. The patient has recovered.
Patient Sequence No: 1, Text Type: D, B5
[16296943]
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
| Report Number | 9615728-2015-00005 |
| MDR Report Key | 4808045 |
| Report Source | 01,07,08 |
| Date Received | 2015-05-29 |
| Date of Report | 2015-05-01 |
| Date of Event | 2015-02-26 |
| 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 DE NATIONS, PARIS NORD 2 383 RUE DE LA BELLE ETOILE |
| Manufacturer City | ETOLLE ROSSY CH DE GAULLE CEDE |
| Manufacturer Country | FR |
| Manufacturer Phone | 4817252 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | EMBOSPHERE MICROSPHERES |
| 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 | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BIOSPHERE MEDICAL, S.A. |
| Manufacturer Address | ETOLLE ROSSY CH DE GAULLE CEDE FR |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization; 2. Other | 2015-05-29 |