MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-04-19 for EMBOSPHERE MICROSPHERES manufactured by Biosphere Medical Sa.
[43016135]
No device is expected to be returned for evaluation. Because no unit from the same lot was returned, a formal investigation of the affected device could not be completed and the root cause could not be determined. Since the lot number was not provided, the device history record could not be reviewed. The review of the complaint data base over the last four years did not report any similar adverse event. Device is a permanent implant.
Patient Sequence No: 1, Text Type: N, H10
[43016136]
The user reported that after the treatment of a benign prostatic hyperplasia with embolics, the patient developed a full body rash. The rash became desquamating over the next few days and there are multiple erythematous patches remaining several months after the procedure.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9615728-2016-00001 |
| MDR Report Key | 5587060 |
| Date Received | 2016-04-19 |
| Date of Report | 2016-03-24 |
| Date of Event | 2016-01-26 |
| Date Mfgr Received | 2016-03-24 |
| Date Added to Maude | 2016-04-19 |
| 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 |
| Reporter Occupation | RISK MANAGER |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MRS ALIX FONLLADOSA |
| Manufacturer Street | PARC DES NATIONS-PARIS NORD 2 383, RUE DE LA BELLE ETOILE |
| Manufacturer City | ROISSY- EN- FRANCE, 95700 |
| Manufacturer Country | FR |
| Manufacturer Postal | 95700 |
| Manufacturer Phone | 3314817252 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | EMBOSPHERE MICROSPHERES |
| Generic Name | EMBOSPHERE MICROSPHERES |
| Product Code | NAJ |
| Date Received | 2016-04-19 |
| Operator | PHYSICIAN |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BIOSPHERE MEDICAL SA |
| Manufacturer Address | PARC DES NATIONS-PARIS NORD 2 383, RUE DE LA BELLE ETOILE ROISSY EN FRANCE 95700 US 95700 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2016-04-19 |