MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-12-08 for LEICA RM2255 1492255UL01 manufactured by Leica Biosystems Nussloch Gmbh.
[94270573]
On (b)(6) 2017, leica biosystems was notified that a lab tech injured (cut) his finger during usage of the microtome instrument. Medical treatment was necessary. According to the customer, the incident occurred on (b)(6) 2017. As per the manufacturer investigation, the user disregarded the instrument safety instructions resulting in the injury. Safety training was performed with the user following this incident.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1423337-2017-00020 |
| MDR Report Key | 7100546 |
| Date Received | 2017-12-08 |
| Date of Report | 2017-11-10 |
| Date of Event | 2017-10-20 |
| Date Facility Aware | 2017-11-10 |
| Report Date | 2017-12-08 |
| Date Reported to FDA | 2017-12-08 |
| Date Reported to Mfgr | 2017-12-08 |
| Date Added to Maude | 2017-12-08 |
| 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 | 2017-12-08 |
| Model Number | 1492255UL01 |
| Device Availability | Y |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | LEICA BIOSYSTEMS NUSSLOCH GMBH |
| Manufacturer Address | HEIDELBERGERSTR. 17-19 NUSSLOCH, 69226 GM 69226 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2017-12-08 |