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 2018-02-15 for EMBOSPHERE MICROSPHERES S820GH/JPA manufactured by Biosphere Medical Sa.
[100234818]
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
[100234819]
On (b)(6) 2016 a uterine artery embolization (uae) was performed. On (b)(6) 2016 the patient was discharged from hospital. On (b)(6) 2016 pyrexia and malodorous discharge developed. On (b)(6) 2016 the patient visited the outpatient department and started receiving oral administration of an antibiotic. However, no improvements in symptoms were noted. On (b)(6) 2016 the white blood cell (wbc) count and c-reactive protein (crp) level increased. The patient was thus hospitalized. Antibiotic therapy was initiated and continued until for one week. On (b)(6) 2016 laboratory data showed little improvement. Administration of fesin was initiated and continued until (b)(6) 2016 to improve anemia. Magnetic resonance imaging revealed production of intrauterine gas and urgent surgical procedure was considered necessary. Abdominal total hysterectomy (ath) was thus performed. Adona and transamin were administered for postoperative hemostasis. The patient made good progress after the procedure. On (b)(6) 2016 the patient was discharged from hospital.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9615728-2018-00001 |
| MDR Report Key | 7275465 |
| Report Source | COMPANY REPRESENTATIVE,DISTRI |
| Date Received | 2018-02-15 |
| Date of Report | 2018-01-29 |
| Date of Event | 2016-05-17 |
| Date Mfgr Received | 2018-01-29 |
| Date Added to Maude | 2018-02-15 |
| 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 |
| Manufacturer Street | 1600 W MERIT PARKWAY |
| Manufacturer City | SOUTH JORDAN 84095 |
| Manufacturer Country | US |
| Manufacturer Postal | 84095 |
| Manufacturer Phone | 8012081600 |
| Manufacturer G1 | BIOSPHERE MEDICAL SA |
| Manufacturer Street | PARC DES NATIONS PARIS NORD 2 |
| Manufacturer City | 383, RUE DE LA BELLE ETOILE, 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 | 2018-02-15 |
| 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, 95700 FR 95700 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization; 2. Required No Informationntervention | 2018-02-15 |