MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative report with the FDA on 2019-09-03 for SURGICAL MANAGEMENT 2018.01.02 - 2018.01.09 N/A manufactured by Cerner Corporation.
| Report Number | 1931259-2019-00006 |
| MDR Report Key | 8955831 |
| Report Source | COMPANY REPRESENTATIVE |
| Date Received | 2019-09-03 |
| Date of Report | 2019-09-03 |
| Date of Event | 2018-07-27 |
| Date Mfgr Received | 2018-07-27 |
| Device Manufacturer Date | 2018-06-06 |
| Date Added to Maude | 2019-09-03 |
| 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. SHELLEY LOOBY |
| Manufacturer Street | 2800 ROCK CREEK PARKWAY |
| Manufacturer City | KANSAS CITY MO 64117 |
| Manufacturer Country | US |
| Manufacturer Postal | 64117 |
| Manufacturer Phone | 8162011368 |
| Manufacturer G1 | CERNER CORPORATION |
| Manufacturer Street | 2800 ROCK CREEK PARKWAY |
| Manufacturer City | KANSAS CITY MO 64117 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 64117 |
| Single Use | 3 |
| Remedial Action | NO |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | SURGICAL MANAGEMENT |
| Generic Name | SOFTWARE |
| Product Code | LNX |
| Date Received | 2019-09-03 |
| Model Number | 2018.01.02 - 2018.01.09 |
| Catalog Number | N/A |
| Lot Number | N/A |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | CERNER CORPORATION |
| Manufacturer Address | 2800 ROCK CREEK PARKWAY KANSAS CITY MO 64117 US 64117 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2019-09-03 |