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 2020-02-21 for APEX? AX1000 manufactured by B. Braun Medical Inc.
| Report Number | 1641965-2020-00005 |
| MDR Report Key | 9738882 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2020-02-21 |
| Date of Report | 2020-02-21 |
| Date of Event | 2020-01-28 |
| Date Mfgr Received | 2020-01-28 |
| Date Added to Maude | 2020-02-21 |
| 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 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MR. JONATHAN SEVERINO |
| Manufacturer Street | 861 MARCON BLVD. |
| Manufacturer City | ALLENTOWN PA 18109 |
| Manufacturer Country | US |
| Manufacturer Postal | 18109 |
| Manufacturer Phone | 4847197287 |
| Manufacturer G1 | B. BRAUN MEDICAL INC |
| Manufacturer Street | 1601 WALLACE DRIVE, SUITE 150 |
| Manufacturer City | CARROLLTON TX 750066690 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 750066690 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | APEX? |
| Generic Name | COMPOUNDER |
| Product Code | NEP |
| Date Received | 2020-02-21 |
| Model Number | AX1000 |
| Catalog Number | AX1000 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | B. BRAUN MEDICAL INC |
| Manufacturer Address | 1601 WALLACE DRIVE, SUITE 150 CARROLLTON TX 750066690 US 750066690 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-02-21 |