MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-11-01 for PELORIS RAPID TISSUE PROCESSOR 26.0005 manufactured by Leica Biosystems Melbourne Pty. Ltd.
Report Number | 1423337-2019-00012 |
MDR Report Key | 9267401 |
Date Received | 2019-11-01 |
Date of Report | 2019-11-06 |
Date of Event | 2019-10-02 |
Date Facility Aware | 2019-10-02 |
Report Date | 2019-11-06 |
Date Reported to FDA | 2019-11-06 |
Date Reported to Mfgr | 2019-11-06 |
Date Added to Maude | 2019-11-01 |
Event Key | 0 |
Report Source Code | Distributor 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 | OTHER HEALTH CARE PROFESSIONAL |
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 | 3 |
Brand Name | PELORIS RAPID TISSUE PROCESSOR |
Generic Name | AUTOMATED TISSUE PROCESSOR |
Product Code | IEO |
Date Received | 2019-11-01 |
Model Number | PELORIS |
Catalog Number | 26.0005 |
Device Availability | Y |
Device Age | DA |
Device Eval'ed by Mfgr | * |
Device Sequence No | 1 |
Device Event Key | 0 |
Manufacturer | LEICA BIOSYSTEMS MELBOURNE PTY. LTD |
Manufacturer Address | 495 BLACKBURN ROAD MOUNT WAVERLEY, 3149 AS 3149 |
Patient Number | Treatment | Outcome | Date |
---|---|---|---|
1 | 0 | 1. Other | 2019-11-01 |