MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2014-11-10 for FINESSE FINESSE ME 77500102 manufactured by Thermo Scientific.
[4987479]
The histology employee was using the micro-tome device to process a tissue specimen. She pushed the stop button on the micro-tome but it continued to run as she was trying to get a hold of the tissue. The employee's finger was caught in the blade and cut off near tip of her right index finger.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 4251828 |
| MDR Report Key | 4251828 |
| Date Received | 2014-11-10 |
| Date of Report | 2014-10-15 |
| Date of Event | 2014-10-13 |
| Date Facility Aware | 2014-10-13 |
| Report Date | 2014-10-15 |
| Date Reported to Mfgr | 2014-10-15 |
| Date Added to Maude | 2014-11-18 |
| Event Key | 0 |
| Report Source Code | User Facility 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 | BIOMEDICAL ENGINEER |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | FINESSE |
| Generic Name | MICROTOME |
| Product Code | IDO |
| Date Received | 2014-11-10 |
| Model Number | FINESSE ME |
| Catalog Number | 77500102 |
| ID Number | HOSP ID-CE4762 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | 13 YR |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | THERMO SCIENTIFIC |
| Manufacturer Address | KALAMAZOO MI US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2014-11-10 |