MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1997-12-23 for LIPOSORBER LA-15 KACLA15 manufactured by Kaneka Corp..
[74645]
The pt started his first ldl apheresis treatment using liposorber la-15 sys on november 11, 1992. The pt experienced an adverse event of sudden loss of hearing (right > left) with vertigo in another country on november 21, 1995, after 3500 ml of plasma was treated. The symptoms appeared to have only been partially resolved with continued possible hearing impairment in the pt's right ear. However, the treating physician has not supplied updated info. The pt has continued his ldl apheresis procedures and has not had any further neurological or new hearing problems.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2435151-1997-00001 |
| MDR Report Key | 140028 |
| Date Received | 1997-12-23 |
| Date of Report | 1997-12-23 |
| Date of Event | 1995-11-21 |
| Date Facility Aware | 1997-03-12 |
| Report Date | 1997-12-23 |
| Date Added to Maude | 1997-12-30 |
| Event Key | 0 |
| Report Source Code | Distributor report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 0 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | LIPOSORBER LA-15 |
| Generic Name | LDL ADSORPTION COLUMN |
| Product Code | MMY |
| Date Received | 1997-12-23 |
| Model Number | LIPOSORBER LA-15 |
| Catalog Number | KACLA15 |
| Lot Number | UNK |
| ID Number | UNK |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | UNKNOWN |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 136709 |
| Manufacturer | KANEKA CORP. |
| Manufacturer Address | 3-2-4, NAKANOSHIMA, KITA-KU OSAKA JA 530-8288 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 1997-12-23 |