MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a other report with the FDA on 2020-03-26 for POST CRANIOTOMY SUBDURAL PRESSURE MONITORING KIT 1104G manufactured by (design And Production) Natus Medical Incorporated.
Report Number | 2023988-2020-00009 |
MDR Report Key | 9886481 |
Report Source | OTHER |
Date Received | 2020-03-26 |
Date of Report | 2020-03-26 |
Date of Event | 2020-03-03 |
Date Added to Maude | 2020-03-26 |
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 | TONI GORMAN |
Manufacturer Street | 5955 PACIFIC CENTER BLVD |
Manufacturer City | SAN DIEGO, |
Manufacturer Country | US |
Manufacturer G1 | NATUS MEDICAL INCORPORATED |
Manufacturer Street | 5955 PACIFIC CENTER BLVD |
Manufacturer City | SAN DIEGO, |
Manufacturer Country | US |
Single Use | 3 |
Previous Use Code | 3 |
Event Type | 3 |
Type of Report | 3 |
Brand Name | POST CRANIOTOMY SUBDURAL PRESSURE MONITORING KIT |
Generic Name | POST CRANIOTOMY SUBDURAL PRESSURE MONITORING KIT |
Product Code | GWM |
Date Received | 2020-03-26 |
Model Number | 1104G |
Catalog Number | 1104G |
Device Availability | * |
Device Eval'ed by Mfgr | * |
Device Sequence No | 1 |
Device Event Key | 0 |
Manufacturer | (DESIGN AND PRODUCTION) NATUS MEDICAL INCORPORATED |
Manufacturer Address | 5955 PACIFIC CENTER BLVD SAN DIEGO US |
Patient Number | Treatment | Outcome | Date |
---|---|---|---|
1 | 0 | 2020-03-26 |