MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2010-12-22 for HM3555 manufactured by Microtome Intl Thermal Scientific.
[15211323]
Lab employee was operating the rotary microtome. The machine was in manual mode, but the f3 fuse was blown. This affected the automatic brake. While the blade was returning to counterbalance, the employee cut off the distal tip of her index finger, necessitating surgical repair. On (b)(6) 2010, employee was seen in the er immediately following the injury. The wound was cleaned and dressed, but the tip was not reattached. The following day, the pt underwent surgical closure.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5018693 |
| MDR Report Key | 1938537 |
| Date Received | 2010-12-22 |
| Date of Report | 2010-12-10 |
| Date of Event | 2010-12-02 |
| Date Added to Maude | 2011-01-04 |
| Event Key | 0 |
| Report Source Code | Voluntary 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 | RISK MANAGER |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Generic Name | ROTARY MICROTOME |
| Product Code | IDP |
| Date Received | 2010-12-22 |
| Model Number | HM3555 |
| ID Number | 0828 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MICROTOME INTL THERMAL SCIENTIFIC |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2010-12-22 |