MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,foreig report with the FDA on 2020-02-20 for FREELITE HUMAN LAMBDA FREE KIT FOR USE ON THE SPAPLUS LK018.S manufactured by The Binding Site Group Limited.
| Report Number | 3012471076-2020-00001 |
| MDR Report Key | 9732510 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2020-02-20 |
| Date of Report | 2020-02-19 |
| Date of Event | 2020-01-08 |
| Date Mfgr Received | 2020-01-21 |
| Device Manufacturer Date | 2019-06-13 |
| Date Added to Maude | 2020-02-20 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 0 |
| Reprocessed and Reused Flag | 3 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | DR RICHARD HUGHES |
| Manufacturer Street | 8 CALTHORPE ROAD |
| Manufacturer City | BIRMINGHAM, B15 1QT |
| Manufacturer Country | UK |
| Manufacturer Postal | B15 1QT |
| Manufacturer G1 | THE BINDING SITE GROUP LIMITED |
| Manufacturer Street | 8 CALTHORPE ROAD |
| Manufacturer City | BIRMINGHAM, B15 1QT |
| Manufacturer Country | UK |
| Manufacturer Postal Code | B15 1QT |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | FREELITE HUMAN LAMBDA FREE KIT FOR USE ON THE SPAPLUS |
| Generic Name | FREELITE HUMAN LAMBDA FREE KIT FOR USE ON THE SPAPLUS |
| Product Code | DEH |
| Date Received | 2020-02-20 |
| Model Number | LK018.S |
| Catalog Number | LK018.S |
| Lot Number | 424735 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | THE BINDING SITE GROUP LIMITED |
| Manufacturer Address | 8 CALTHORPE ROAD BIRMINGHAM, B15 1QT UK B15 1QT |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2020-02-20 |