MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-10-08 for NEURO MONITORING DEVICE manufactured by Unk.
| Report Number | MW5090314 |
| MDR Report Key | 9172893 |
| Date Received | 2019-10-08 |
| Date of Report | 2019-10-06 |
| Date of Event | 2015-01-05 |
| Date Added to Maude | 2019-10-09 |
| Event Key | 0 |
| Report Source Code | Voluntary report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Reporter Occupation | PATIENT |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | NEURO MONITORING DEVICE |
| Generic Name | DEVICE, MONITORING, INTRACRANIAL PRESSURE |
| Product Code | GWM |
| Date Received | 2019-10-08 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | * |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | UNK |
| Manufacturer Address | UNK UNK |
| Brand Name | JACKSON TABLE RESTRAINT STRAPS |
| Generic Name | TABLE AND ATTACHMENTS, OPERATING-ROOM |
| Product Code | BWN |
| Date Received | 2019-10-08 |
| Device Availability | * |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 2 |
| Device Event Key | 0 |
| Manufacturer | UNK |
| Manufacturer Address | UNK UNK |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization; 2. Required No Informationntervention; 3. Deathisabilit | 2019-10-08 |