MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06,07 report with the FDA on 1999-12-23 for VENTANA 300 SERIES 150-300 manufactured by Ventana Medical Systems.
[205056]
Technologist reportedly cut her finger to the bone while using the microtome. Surgery was required to repair the finger.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2030916-1999-00001 |
| MDR Report Key | 256525 |
| Report Source | 06,07 |
| Date Received | 1999-12-23 |
| Date of Report | 1999-12-22 |
| Date of Event | 1999-12-08 |
| Date Mfgr Received | 1999-12-18 |
| Device Manufacturer Date | 1999-03-01 |
| Date Added to Maude | 1999-12-29 |
| 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 | 0 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 0 |
| Manufacturer Contact | STEPHEN TILLSON |
| Manufacturer Street | 3865 N BUSINESS CENTER DR |
| Manufacturer City | TUCSON AZ 85705 |
| Manufacturer Country | US |
| Manufacturer Postal | 85705 |
| Manufacturer Phone | 5206902701 |
| Manufacturer G1 | * |
| Manufacturer Street | * |
| Manufacturer City | * |
| Manufacturer Country | * |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | VENTANA 300 SERIES |
| Generic Name | ROTARY MICROTOME |
| Product Code | IDO |
| Date Received | 1999-12-23 |
| Returned To Mfg | 1999-12-18 |
| Model Number | 300 SERIES |
| Catalog Number | 150-300 |
| Lot Number | NA |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Eval'ed by Mfgr | Y |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 248408 |
| Manufacturer | VENTANA MEDICAL SYSTEMS |
| Manufacturer Address | 3865 N. BUSINESS CTR. DR. TUCSON AZ 85705 US |
| Baseline Brand Name | VENTANASERIES 300 |
| Baseline Generic Name | ROTARY MICROTOME |
| Baseline Model No | 300 SERIES |
| Baseline Catalog No | 150-300 |
| Baseline ID | MT 980 (RMC) |
| Baseline Device Family | MICROTOME, ROTARY |
| Baseline Shelf Life [Months] | NA |
| Baseline PMA Flag | N |
| Baseline 510K PMN | N |
| Baseline Preamendment | N |
| Baseline Transitional | N |
| 510k Exempt | Y |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 1999-12-23 |