MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-01-18 for LEICA CM1950 491950C3US manufactured by Leica Biosystems Nussloch.
[133546538]
On (b)(4) 2018, leica biosystems received a complaint that a resident of the lab injured himself/herself's finger on the blade of the leica cryostat instrument. According to the complainant, the resident of the lab received the "standard post-exposure prophylaxis" treatment. No further treatment details were provided. If additional information becomes available a follow up report will be submitted.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1423337-2019-00001 |
| MDR Report Key | 8261204 |
| Date Received | 2019-01-18 |
| Date of Report | 2019-03-01 |
| Date of Event | 2018-12-14 |
| Date Facility Aware | 2018-12-20 |
| Report Date | 2019-03-01 |
| Date Reported to FDA | 2019-03-01 |
| Date Reported to Mfgr | 2019-03-01 |
| Date Added to Maude | 2019-01-18 |
| 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 CM1950 |
| Generic Name | LEICA CM1950 |
| Product Code | IDP |
| Date Received | 2019-01-18 |
| Model Number | 491950C3US |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | LEICA BIOSYSTEMS NUSSLOCH |
| Manufacturer Address | HEIDELBERGER STRASSE 17-19 NUSSLOCH, 69226 GM 69226 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2019-01-18 |