MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign,health professional report with the FDA on 2019-11-11 for LIXELLE BETA2-MICROGLOBULIN APHERESIS COLUMN S-15 N/A manufactured by Kaneka Corporation.
| Report Number | 3002808904-2019-00030 |
| MDR Report Key | 9303205 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL |
| Date Received | 2019-11-11 |
| Date of Report | 2019-11-06 |
| Date of Event | 2019-10-28 |
| Date Mfgr Received | 2019-11-06 |
| Date Added to Maude | 2019-11-11 |
| 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. YOSHIYUKI KITAMURA |
| Manufacturer Street | 2-3-18 NAKANOSHIMA, KITA-KU |
| Manufacturer City | OSAKA-CITY, OSAKA 530-8288 |
| Manufacturer Country | JA |
| Manufacturer Postal | 530-8288 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | LIXELLE BETA2-MICROGLOBULIN APHERESIS COLUMN |
| Generic Name | BETA2-MICROGLOBULIN APHERESIS COLUMN |
| Product Code | PDI |
| Date Received | 2019-11-11 |
| Model Number | S-15 |
| Catalog Number | N/A |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | KANEKA CORPORATION |
| Manufacturer Address | 2-3-18 NAKANOSHIMA, KITA-KU OSAKA-CITY, OSAKA 530-8288 JA 530-8288 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2019-11-11 |