MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-05-31 for 750-700 05265231001 manufactured by Ventana Medical Systems, Inc.
[46856065]
Na.
Patient Sequence No: 1, Text Type: N, H10
[46856066]
A field service engineer slipped over lcs (oil) that leaked from the instrument. He suffered a bruised rib.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2028492-2016-00002 |
| MDR Report Key | 5690247 |
| Date Received | 2016-05-31 |
| Date of Report | 2016-05-31 |
| Date of Event | 2016-05-02 |
| Date Mfgr Received | 2016-05-02 |
| Date Added to Maude | 2016-05-31 |
| 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 | 3 |
| Event Location | 3 |
| Manufacturer Contact | NA TIM GIBLIN |
| Manufacturer Street | 1910 EAST INNOVATION PARK DR NA |
| Manufacturer City | TUSCON AZ 85755 |
| Manufacturer Country | US |
| Manufacturer Postal | 85755 |
| Manufacturer Phone | 5208777035 |
| Manufacturer G1 | VENTANA MEDICAL SYSTEMS, INC |
| Manufacturer Street | 1910 E INNOVATION PARK DR NONE |
| Manufacturer City | TUCSON AZ |
| Single Use | 3 |
| Previous Use Code | 3 |
| Removal Correction Number | NA |
| Event Type | 3 |
| Type of Report | 0 |
| Generic Name | BENCHMARK XT |
| Product Code | NQN |
| Date Received | 2016-05-31 |
| Model Number | 750-700 |
| Catalog Number | 05265231001 |
| Lot Number | N/A |
| ID Number | UDI# 04015630981069 |
| Operator | SERVICE AND TESTING PERSONNEL |
| Device Availability | * |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | VENTANA MEDICAL SYSTEMS, INC |
| Manufacturer Address | 1910 E INNOVATION PARK DRIVE 1910 E INNOVATION PARK DRIVE TUCSON AZ 857551962 US 857551962 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2016-05-31 |