MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2000-03-30 for UNK CUT 4055 manufactured by Olympus America, Inc..
[179699]
Histology tech was cutting paraffin blocks. Second tech assisting did not lock the wheel when leaving the machine. First tech went to put on next block and knife grabbed their left thumb and cut it. Laceration 1-2 cm required stitches in following: wound edges of nail bed, nail bed, beyond tip of nail, thumb nail. Tetanus injection given.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 271791 |
| MDR Report Key | 271791 |
| Date Received | 2000-03-30 |
| Date of Report | 2000-03-28 |
| Date of Event | 2000-01-13 |
| Date Facility Aware | 2000-01-13 |
| Report Date | 2000-03-28 |
| Date Reported to FDA | 2000-03-28 |
| Date Added to Maude | 2000-04-04 |
| 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 | 0 |
| 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 | UNK |
| Generic Name | MICROTOME |
| Product Code | IDW |
| Date Received | 2000-03-30 |
| Model Number | CUT 4055 |
| Catalog Number | UNK |
| Lot Number | UNK |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | UNKNOWN |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 263113 |
| Manufacturer | OLYMPUS AMERICA, INC. |
| Manufacturer Address | * * * |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2000-03-30 |