MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2019-01-18 for LEICA CM1950 1491950C3US manufactured by Leica Biosystems Nussloch Gmbh.
[133562245]
An investigation of the incident is currently underway and a follow up will be submitted should additional information become available following the investigation.
Patient Sequence No: 1, Text Type: N, H10
[133562246]
On 20 december 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 postexposure 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 | 8010478-2019-00001 |
| MDR Report Key | 8261608 |
| Report Source | HEALTH PROFESSIONAL |
| Date Received | 2019-01-18 |
| Date of Report | 2019-01-18 |
| Date of Event | 2018-12-14 |
| Date Mfgr Received | 2018-12-20 |
| Device Manufacturer Date | 2015-11-19 |
| Date Added to Maude | 2019-01-18 |
| 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 |
| 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 | 1491950C3US |
| Device Availability | Y |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | LEICA BIOSYSTEMS NUSSLOCH GMBH |
| Manufacturer Address | HEIDELBERGER STRASSE 17-19 NUSSLOCH, 69226 GM 69226 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2019-01-18 |