MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2014-05-15 for LEICA CM1850UV 149185O0UVUL manufactured by Leica Biosystems Nussloch Gmbh.
[4410881]
The customer got an injury to his right thumb whilst removing the debris from the unit. He states the there was a knife still in the instrument. He has cut his thumb due to the sharp edge on the microtome blade. Medical treatment was necessary.
Patient Sequence No: 1, Text Type: D, B5
[11964257]
The investigation revealed the following: this incident was user related, because during the removing of debris there was a knife still in the unit, and the user has forgotten to remove the knife before, respectively to use the blade guard. A customer facing letter will be sent to the customer with the recommendation in future to follow the description provided in the instructions for use.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 8010478-2014-00006 |
| MDR Report Key | 3839183 |
| Report Source | 05 |
| Date Received | 2014-05-15 |
| Date of Report | 2014-04-22 |
| Date of Event | 2014-04-21 |
| Date Mfgr Received | 2014-04-22 |
| Date Added to Maude | 2014-05-30 |
| 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 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | ROBERT GROPP |
| Manufacturer Street | HEIDELBERGER STR. 17-19 |
| Manufacturer City | NUSSLOCH 69226 |
| Manufacturer Country | GM |
| Manufacturer Postal | 69226 |
| Manufacturer Phone | 224143345 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | LEICA CM1850UV |
| Generic Name | NONE |
| Product Code | IDP |
| Date Received | 2014-05-15 |
| Model Number | 149185O0UVUL |
| Operator | HEALTH PROFESSIONAL |
| 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 STR. 17-19 NUSSLOCH 69226 GM 69226 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2014-05-15 |