MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,health report with the FDA on 2019-11-05 for LEVEL ONE CMF UNKNOWN manufactured by Karl Leibinger Medizintechnik Gmbh & Co. Kg.
| Report Number | 9610905-2019-00194 |
| MDR Report Key | 9280131 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2019-11-05 |
| Date of Report | 2019-10-15 |
| Date of Event | 2019-10-15 |
| Date Facility Aware | 2019-10-15 |
| Report Date | 2019-10-15 |
| Date Reported to Mfgr | 2019-10-15 |
| Date Mfgr Received | 2019-10-15 |
| Date Added to Maude | 2019-11-05 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MS. JENNIFER DAMATO |
| Manufacturer Street | P.O. BOX 16369 |
| Manufacturer City | JACKSONVILLE FL 32245 |
| Manufacturer Country | US |
| Manufacturer Postal | 32245 |
| Manufacturer Phone | 9046417746 |
| Manufacturer G1 | KARL LEIBINGER MEDIZINTECHNIK GMBH & CO. KG |
| Manufacturer Street | KOLBINGER STRASSE 10 |
| Manufacturer City | MUEHLHEIM/DONAU, 78570 |
| Manufacturer Country | GM |
| Manufacturer Postal Code | 78570 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | LEVEL ONE CMF |
| Generic Name | PLATE |
| Product Code | MQN |
| Date Received | 2019-11-05 |
| Model Number | UNKNOWN |
| Lot Number | UNKNOWN |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | KARL LEIBINGER MEDIZINTECHNIK GMBH & CO. KG |
| Manufacturer Address | KOLBINGER STRASSE 10 MUEHLHEIM/DONAU, 78570 GM 78570 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2019-11-05 |