MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2019-10-22 for LEICA RM2235 14D22350001 manufactured by Leica Biosystems Nussloch Gmbh.
| Report Number | 8010478-2019-00008 |
| MDR Report Key | 9217245 |
| Report Source | HEALTH PROFESSIONAL |
| Date Received | 2019-10-22 |
| Date of Report | 2019-11-28 |
| Date of Event | 2019-09-23 |
| Date Mfgr Received | 2019-09-23 |
| Device Manufacturer Date | 2008-11-20 |
| Date Added to Maude | 2019-10-22 |
| 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 | MR. ROBERT GROPP |
| Manufacturer Street | HEIDELBERGERSTR. 17-19 |
| Manufacturer City | NUSSLOCH, 69226 |
| Manufacturer Country | GM |
| Manufacturer Postal | 69226 |
| Manufacturer G1 | LEICA MICROSYSTEMS LTD. SHANGHAI |
| Manufacturer Street | BUILDING 1, 258 JINZANG ROAD |
| Manufacturer City | PUDONG, SHANGHAI 201206, CH, 201206 |
| Manufacturer Country | CH |
| Manufacturer Postal Code | 201206 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | LEICA RM2235 |
| Generic Name | LEICA RM2235 |
| Product Code | IDO |
| Date Received | 2019-10-22 |
| Model Number | 14D22350001 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | LEICA BIOSYSTEMS NUSSLOCH GMBH |
| Manufacturer Address | HEIDELBERGERSTR. 17-19 NUSSLOCH, 69226 GM 69226 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2019-10-22 |