MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,foreig report with the FDA on 2018-10-05 for BIOSPHERE EMBOSPHERES S220GH/JPA manufactured by Biosphere Medical Sa.
[122825728]
The suspect device is not expected to return for evaluation. A review of the device history and complaint database could not be performed since the lot number was not provided.
Patient Sequence No: 1, Text Type: N, H10
[122825729]
The account alleges that on (b)(6) 2016 the patient underwent a pre-operative embolization procedure. Embolization particles were injected into the right middle meningeal artery. Right eye pain and visual impairment were noted. Imaging of the right internal carotid artery was performed, and central retinal artery occlusion was diagnosed as a result. The patient was sent to the department of ophthalmology and received eye massage and anterior chamber puncture. Treatment was performed with continuous drip infusion of heparin (1500 u/day) from (b)(6) 2018 and dexart (dexamethasone sodium phosphate, 3. 3 mg/day) was administered on (b)(6) 2016 - (b)(6) 2016. On (b)(6) 2016, right visual impairment persisted. The scheduled tumorectomy was postponed and the patient was discharged to home. On (b)(6) 2016 the patient was hospitalized again. On (b)(6) 2016 a resection of intracranial tumor was performed. On (b)(6) 2016, the patient was discharged home still experiencing right visual impairment.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9615728-2018-00002 |
| MDR Report Key | 7938222 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2018-10-05 |
| Date of Report | 2018-09-21 |
| Date of Event | 2016-07-26 |
| Date Mfgr Received | 2018-09-21 |
| Date Added to Maude | 2018-10-05 |
| 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 | MRS. KATIE SWENSON CQE,CBA,CQPA. |
| Manufacturer Street | 1600 MERIT PARKWAY |
| Manufacturer City | SOUTH JORDAN UT 84095 |
| Manufacturer Country | US |
| Manufacturer Postal | 84095 |
| Manufacturer Phone | 8012531600 |
| Manufacturer G1 | BIOSPHERE MEDICAL SA |
| Manufacturer Street | PARC DES NATIONS, PARIS NORD 2 383, RUE DE LA BELLE ETOILE |
| Manufacturer City | 95700 |
| Manufacturer Country | FR |
| Manufacturer Postal Code | 95700 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | BIOSPHERE EMBOSPHERES |
| Generic Name | EMBOSPHERES |
| Product Code | NAJ |
| Date Received | 2018-10-05 |
| Catalog Number | S220GH/JPA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | N |
| 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 95700 FR 95700 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization; 2. Required No Informationntervention; 3. Deathisabilit | 2018-10-05 |