FDA Adverse Event
Injury
Summary report: N
EXTRACORPOREAL FILTER
MDR report key: 21251
·
Received January 21, 1995
Report
- Report Number
- 1036499-1995-00003
- Event Type
- Injury
- Date Received
- January 21, 1995
- Manufacturer
- PALL BIOMEDICAL PRODUCTS COMPANY
- Product Code
- LLB
- Report Source
- Distributor report
- Reporter Location
- FL, US
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 1
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).
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | EXTRACORPOREAL FILTER | PROFUSION DEVICE | LLB | PALL BIOMEDICAL PRODUCTS COMPANY | LG-6 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | * | Life Threatening | PRODUCTS, INC.| MODEL LG-6 EXTRACORPOREAL FILTER-PALL BIOMEDICAL |