MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,05 report with the FDA on 1998-12-16 for LIPOSORBER LA-15 LDL ADSORPTION COLUMN UNK manufactured by Kaneka Corp..
[116827]
Pt's bloodflow was insufficient for treatment with ldl apheresis. After treatment of 2,100 ml of plasma using heparin as an anticoagulant, pt experienced hypotensive shock. Treatment was discontinued.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2435151-1998-00008 |
| MDR Report Key | 202451 |
| Report Source | 01,05 |
| Date Received | 1998-12-16 |
| Date of Report | 1998-12-14 |
| Date of Event | 1998-10-30 |
| Date Mfgr Received | 1998-10-30 |
| Device Manufacturer Date | 1997-11-01 |
| Date Added to Maude | 1998-12-21 |
| 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 | 0 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 0 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | LIPOSORBER LA-15 LDL ADSORPTION COLUMN |
| Generic Name | LDL ADSORPTION SYSTEM |
| Product Code | MMY |
| Date Received | 1998-12-16 |
| Model Number | UNK |
| Catalog Number | UNK |
| Lot Number | UNK |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 196646 |
| Manufacturer | KANEKA CORP. |
| Manufacturer Address | 3-2-4 NAKANOSHIMA, KITA-KU OSAKA JA 530-8288 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 3 | 1. Other | 1998-12-16 |