MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 99 report with the FDA on 2014-05-16 for LEICA CM1850UV 1491850UVUL manufactured by Leica Biosystems Nussloch Gmbh.
[20976988]
On (b)(6) 2014, leica biosystems was notified that a user injured his right thumb while removing debris from the instrument. The customer states that a knife was still in the instrument and his thumb was cut due to the sharp edge on the blade. Medical treatment was necessary.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1423337-2014-00004 |
| MDR Report Key | 3876187 |
| Report Source | 99 |
| Date Received | 2014-05-16 |
| Date of Report | 2014-04-22 |
| Date of Event | 2014-04-21 |
| Date Facility Aware | 2014-04-22 |
| Report Date | 2014-04-22 |
| Date Reported to FDA | 2014-05-16 |
| Date Reported to Mfgr | 2014-05-16 |
| Date Added to Maude | 2014-06-18 |
| 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 | 0 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | LEICA CM1850UV |
| Generic Name | NONE |
| Product Code | IDP |
| Date Received | 2014-05-16 |
| Model Number | 1491850UVUL |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| 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 | 2014-05-16 |