MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,06 report with the FDA on 1998-03-09 for LIPOSORBER LA-15 SYSTEM LIPOSORBER LA-40 NA manufactured by Kaneka Corp..
[106339]
Immediately after the start of plasma processing, the pt went into shock and was moved to the intensive care unit. The treating physician determined this to be an anaphylactoid reaction. This med device is not distributed in the united states. However, the materials used in the liposorber la-40 are the same as those used in the la-15 which is a component of the liposorber la-15 system.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2435151-1998-00004 |
| MDR Report Key | 154788 |
| Report Source | 01,06 |
| Date Received | 1998-03-09 |
| Date of Report | 1995-08-08 |
| Date of Event | 1995-08-08 |
| Date Mfgr Received | 1995-08-08 |
| Device Manufacturer Date | 1994-12-01 |
| Date Added to Maude | 1998-03-11 |
| 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 | 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 SYSTEM |
| Generic Name | LDL ADSORPTION SYSTEM |
| Product Code | MMY |
| Date Received | 1998-03-09 |
| Model Number | LIPOSORBER LA-40 |
| Catalog Number | NA |
| Lot Number | NA |
| ID Number | NA |
| Device Expiration Date | 1998-12-01 |
| 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 | 150783 |
| Manufacturer | KANEKA CORP. |
| Manufacturer Address | 3-2-4, NAKANOSHIMA, KITA-KU OSAKA JA 5308288 |
| Baseline Brand Name | LIPOSORBER LA-15 SYSTEM |
| Baseline Generic Name | LDL ADSORPTION SYSTEM |
| Baseline Model No | LIPOSORBER LA-4 |
| Baseline Catalog No | NA |
| Baseline ID | NA |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Life Threatening | 1998-03-09 |