MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1995-01-21 for EXTRACORPOREAL FILTER LG-6 manufactured by Pall Biomedical Products Company.
[11093]
Attached to the original is the perfusion record received from the pall regional representative who, in turn received it from the hospital. The event description was not written out iadequate form for data entry. (see original/hard copy).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1036499-1995-00003 |
| MDR Report Key | 21251 |
| Date Received | 1995-01-21 |
| Date Reported to Mfgr | 1995-02-03 |
| Date Added to Maude | 1995-04-20 |
| 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 | EXTRACORPOREAL FILTER |
| Generic Name | PROFUSION DEVICE |
| Product Code | LLB |
| Date Received | 1995-01-21 |
| Returned To Mfg | 1995-01-12 |
| Model Number | LG-6 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | * |
| Implant Flag | N |
| Date Removed | B |
| Device Sequence No | 1 |
| Device Event Key | 21238 |
| Manufacturer | PALL BIOMEDICAL PRODUCTS COMPANY |
| Manufacturer Address | DIVISION OF PALL CORPORATION 2220 NORTHERN BOULEVARD EAST HILLS NY 11548 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Life Threatening | 1995-01-21 |