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 2019-11-26 for ABL800 393-800 manufactured by Radiometer Medical Aps.
| Report Number | 3002807968-2019-00055 |
| MDR Report Key | 9377356 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2019-11-26 |
| Date of Report | 2019-11-26 |
| Date of Event | 2019-11-11 |
| Date Mfgr Received | 2019-11-11 |
| Device Manufacturer Date | 2009-08-14 |
| Date Added to Maude | 2019-11-26 |
| 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. BOLETTE DUUN-CHRISTENSEN |
| Manufacturer Street | AAKANDEVEJ 21 |
| Manufacturer City | BROENSHOEJ, 2700 |
| Manufacturer Country | DA |
| Manufacturer Postal | 2700 |
| Manufacturer G1 | RADOMETER MEDICAL APS |
| Manufacturer Street | AAKANDEVEJ 21 |
| Manufacturer City | BROENSHOEJ, 2700 |
| Manufacturer Country | DA |
| Manufacturer Postal Code | 2700 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ABL800 |
| Generic Name | ABL800 FLEX |
| Product Code | CHL |
| Date Received | 2019-11-26 |
| Model Number | 393-800 |
| Catalog Number | 393-800 |
| Device Availability | N |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | RADIOMETER MEDICAL APS |
| Manufacturer Address | AAKANDEVEJ 21 BROENSHOEJ, 2700 DA 2700 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2019-11-26 |