MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,distri report with the FDA on 2017-08-17 for EMBOSPHERE MICROSPHERES S820GH/JPA manufactured by Biosphere Medical Sa.
[82979937]
The suspect device is not expected to return for evaluation. A review of the complaint database and device history record could not be performed since the lot number was not provided.
Patient Sequence No: 1, Text Type: N, H10
[82979938]
The account reports uterine artery embolization was performed on an unknown date. On an unknown date, an infection developed. The cause of the infection was unknown. The patient was re-hospitalized after discharge. On (b)(6) 2017 the infection had improved and the patient had recovered.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9615728-2017-00021 |
| MDR Report Key | 6802388 |
| Report Source | COMPANY REPRESENTATIVE,DISTRI |
| Date Received | 2017-08-17 |
| Date of Report | 2017-08-14 |
| Date of Event | 2017-04-10 |
| Date Mfgr Received | 2017-08-08 |
| Date Added to Maude | 2017-08-17 |
| 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 | MR. CASEY HUGHES, MS, CQE, CSQP |
| Manufacturer Street | 1600 MERIT PARKWAY |
| Manufacturer City | SOUTH JORDAN UT 94095 |
| Manufacturer Country | US |
| Manufacturer Postal | 94095 |
| Manufacturer Phone | 8012531600 |
| Manufacturer G1 | BIOSPHERE MEDICAL SA |
| 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 Code | 95700 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | EMBOSPHERE MICROSPHERES |
| Generic Name | MICROSPHERES |
| Product Code | NAJ |
| Date Received | 2017-08-17 |
| Catalog Number | S820GH/JPA |
| Operator | HEALTH PROFESSIONAL |
| 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 FR 95700 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization | 2017-08-17 |