MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2020-03-19 for LEICA CM1950 1491950C4US manufactured by Leica Biosystems Nussloch Gmbh.
[184321475]
The field service specialist tried three times to contact the customer with no response. No further information or confirmation of medical treatment was provided by the customer.
Patient Sequence No: 1, Text Type: N, H10
[184321476]
On (b)(6) 2020, leica biosystems received a complaint that the customer cut her finger during the cleaning of the microtome cryostat. No further information or confirmation of medical treatment was provided by the customer.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 8010478-2020-00005 |
| MDR Report Key | 9853305 |
| Report Source | HEALTH PROFESSIONAL |
| Date Received | 2020-03-19 |
| Date of Report | 2020-03-25 |
| Date of Event | 2020-03-04 |
| Date Mfgr Received | 2020-03-20 |
| Device Manufacturer Date | 2015-08-24 |
| Date Added to Maude | 2020-03-19 |
| 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 | 2020-03-19 |
| Model Number | 1491950C4US |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | N |
| 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 | 2020-03-19 |