MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06 report with the FDA on 1998-05-04 for LIPOSORBER LA-15 LDL ADSORPTION COLUMN LIPOSORBER IA-15 KACLA15 manufactured by Kaneka Corp..
[84258]
Subject experienced hypotension and chest pain while undergoing apheresis. Prior administration of "ace" inhibitor thought to be responsible. Acute myocardial infarct was ruled out with enzymes. Intravenous saline administered, and pt transferred to "ccv".
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2435151-1998-00007 |
| MDR Report Key | 166068 |
| Report Source | 06 |
| Date Received | 1998-05-04 |
| Date of Report | 1998-05-01 |
| Date of Event | 1998-03-23 |
| Date Facility Aware | 1998-04-02 |
| Report Date | 1998-05-01 |
| Date Reported to FDA | 1998-05-01 |
| Date Reported to Mfgr | 1998-04-02 |
| Date Mfgr Received | 1998-04-02 |
| Date Added to Maude | 1998-05-07 |
| 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 | 3 |
| 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 ABSORPTION SYSTEM |
| Product Code | MMY |
| Date Received | 1998-05-04 |
| Model Number | LIPOSORBER IA-15 |
| Catalog Number | KACLA15 |
| Lot Number | N/A |
| ID Number | N/A |
| 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 | 161613 |
| Manufacturer | KANEKA CORP. |
| Manufacturer Address | 3-2-4, NAKANOSHIMA KITA-KU OSAKA JA 5308288 |
| Baseline Brand Name | LIPOSORBER IA-15 SYSTEM |
| Baseline Generic Name | LDL ABSORPTION SYSTEM |
| Baseline Model No | LIPOSORBER IA-1 |
| Baseline Catalog No | N/A |
| Baseline ID | N/A |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization | 1998-05-04 |