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 |