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 |