MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-01-20 for LEICA RM2255 1492255UL01 manufactured by Leica Biosystems Nussloch Gmbh.
[65425273]
On (b)(6) 2016, leica biosystems received a complaint that a customer injured her finger during usage of the microtome. Medical treatment was necessary.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1423337-2017-00002 |
| MDR Report Key | 6267794 |
| Date Received | 2017-01-20 |
| Date of Report | 2016-12-21 |
| Date of Event | 2016-12-19 |
| Date Facility Aware | 2016-12-21 |
| Report Date | 2017-01-20 |
| Date Reported to FDA | 2017-01-20 |
| Date Reported to Mfgr | 2017-01-20 |
| Date Added to Maude | 2017-01-20 |
| 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 | LEICA RM2255 |
| Generic Name | MICROTOME |
| Product Code | IDO |
| Date Received | 2017-01-20 |
| Model Number | 1492255UL01 |
| Operator | OTHER HEALTH CARE PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | LEICA BIOSYSTEMS NUSSLOCH GMBH |
| Manufacturer Address | HEIDELBERGERSTR. 17 NUSSLOCH, 69226 GM 69226 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2017-01-20 |