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 2018-04-27 for BIOSPHERE EMBOSPHERES S220GH/JPA manufactured by Biosphere Medical Sa.
[106835722]
The suspect device will not be returned for evaluation since it is a permanent implant which cannot be retrieved. A search of the complaint database and device history record could not be performed because the lot number was not provided.
Patient Sequence No: 1, Text Type: N, H10
[106835723]
The account alleges that a patient was treated via trans arterial embolization [tae] on (b)(6) 2016. On (b)(6) 2016, a biloma had developed. On an unknown date, the biloma had a reduction in size. On an unknown date, a liver abscess had developed, an antibiotic was administered and the patient was hospitalized. On an unknown date, the patient's symptoms had improved so the patient was discharged from hospital. The patient had made satisfactory progress after being discharged but the patient's condition suddenly changed after about 2 weeks. On (b)(6) 2016, the patient died from hepatic failure, multi-organ failure and disseminated intravascular coagulation [dic]. The hepatocellular carcinoma showed no sign of rupture. An infection was considered to be the trigger. Hepatic failure was assessed as unrelated to the embosphere product.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9615728-2018-00005 |
| MDR Report Key | 7470765 |
| Report Source | COMPANY REPRESENTATIVE,DISTRI |
| Date Received | 2018-04-27 |
| Date of Report | 2018-04-19 |
| Date of Event | 2016-10-03 |
| Date Mfgr Received | 2018-04-19 |
| Date Added to Maude | 2018-04-27 |
| 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 | 2018-04-27 |
| Catalog Number | S220GH/JPA |
| 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 95700 FR 95700 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization; 2. Required No Informationntervention | 2018-04-27 |