MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative report with the FDA on 2019-09-16 for PELORIS RAPID TISSUE PROCESSOR PELORIS II 26.0008 manufactured by Leica Biosystems Melbourne Pty. Ltd.
| Report Number | 8020030-2019-00038 |
| MDR Report Key | 9068852 |
| Report Source | COMPANY REPRESENTATIVE |
| Date Received | 2019-09-16 |
| Date of Report | 2019-09-16 |
| Date of Event | 2019-08-19 |
| Date Mfgr Received | 2019-08-22 |
| Device Manufacturer Date | 2010-11-25 |
| Date Added to Maude | 2019-09-16 |
| 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 | MRS ADRIENNE HARDISTY |
| Manufacturer Street | 495 BLACKBURN ROAD |
| Manufacturer City | MOUNT WAVERLEY, 3149 |
| Manufacturer Country | AS |
| Manufacturer Postal | 3149 |
| Manufacturer G1 | LEICA BIOSYSTEMS MELBOURNE PTY. LTD |
| Manufacturer Street | 495 BLACKBURN ROAD |
| Manufacturer City | MOUNT WAVERLEY, 3149 |
| Manufacturer Country | AS |
| Manufacturer Postal Code | 3149 |
| 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 | 2019-09-16 |
| Model Number | PELORIS II |
| Catalog Number | 26.0008 |
| Device Availability | Y |
| Device Eval'ed by Mfgr | Y |
| 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 | 2019-09-16 |