MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1995-03-02 for AIRFLOW WORK STATION 330TS manufactured by Laminaire Corp..
[11522]
Laminar flow hood emits pungent odor through filter.
Patient Sequence No: 1, Text Type: D, B5
Report Number | MW1005293 |
MDR Report Key | 20086 |
Date Received | 1995-03-02 |
Date of Report | 1995-02-15 |
Date of Event | 1995-02-15 |
Date Added to Maude | 1995-03-03 |
Event Key | 0 |
Report Source Code | Voluntary 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 | 0 |
Report to FDA | 0 |
Event Location | 3 |
Single Use | 0 |
Previous Use Code | 0 |
Event Type | 3 |
Type of Report | 3 |
Brand Name | AIRFLOW WORK STATION |
Generic Name | LAMINAR FLOW HOOD |
Product Code | FRF |
Date Received | 1995-03-02 |
Model Number | 330TS |
Operator | HEALTH PROFESSIONAL |
Device Availability | Y |
Implant Flag | N |
Date Removed | B |
Device Sequence No | 1 |
Device Event Key | 19976 |
Manufacturer | LAMINAIRE CORP. |
Manufacturer Address | RAHWAY NJ 070655697 US |
Patient Number | Treatment | Outcome | Date |
---|---|---|---|
1 | 0 | 1995-03-02 |