MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2020-02-11 for OLM INTRACRANIAL PRESSURE MONITORING KIT 1104B manufactured by Natus Medical Incorporated.
Report Number | 2023988-2020-00003 |
MDR Report Key | 9693141 |
Report Source | HEALTH PROFESSIONAL |
Date Received | 2020-02-11 |
Date of Report | 2020-03-11 |
Date Mfgr Received | 2020-01-22 |
Date Added to Maude | 2020-02-11 |
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 | MS CLAIRE KENNEDY |
Manufacturer Street | IDA BUSINESS PARK GORT CO. GALWAY |
Manufacturer City | GALWAY IRELAND H91PD92, |
Manufacturer Country | US |
Manufacturer G1 | NATUS MEDICAL INCORPORATED |
Manufacturer Street | 6701 KOLL CENTER PARKWAY SUITE 120 PLEASANTON |
Manufacturer City | CA 94566 USA, |
Manufacturer Country | US |
Single Use | 3 |
Previous Use Code | 3 |
Event Type | 3 |
Type of Report | 3 |
Brand Name | OLM INTRACRANIAL PRESSURE MONITORING KIT |
Generic Name | OLM INTRACRANIAL PRESSURE MONITORING KIT |
Product Code | GWM |
Date Received | 2020-02-11 |
Returned To Mfg | 2020-02-19 |
Model Number | 1104B |
Catalog Number | 1104B |
Lot Number | 104020-J06 |
Operator | HEALTH PROFESSIONAL |
Device Availability | R |
Device Age | DA |
Device Eval'ed by Mfgr | Y |
Device Sequence No | 1 |
Device Event Key | 0 |
Manufacturer | NATUS MEDICAL INCORPORATED |
Manufacturer Address | 6701 KOLL CENTER PARKWAY SUITE 120 PLEASANTON CA 92121 USA, US |
Patient Number | Treatment | Outcome | Date |
---|---|---|---|
1 | 0 | 1. Other | 2020-02-11 |