MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign report with the FDA on 2019-05-22 for BENCHMARK ULTRA STAINER MODULE 05342716001 manufactured by Ventana Medical Systems Inc.
[145779304]
Through the course of the investigation, no instrument malfunction or leakage was identified. The benchmark ultra user guide provides instructions on how to properly dispose of waste to avoid injury. No additional details surrounding the operator's injury have been provided; it was noted that the customer has been going to physical therapy because of the injury sustained on her right arm and has also been to a neurologist. (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[145779305]
A customer in norway injured her right arm when disposing waste from the ventana benchmark ultra instrument. The customer had a swollen arm with pain. Because of the injury, the customer received a week's sick leave and was back at work after her sick leave. The customer has been going to physical therapy because of the injury sustained on her right arm and has also been to a neurologist.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2028492-2019-00008 |
| MDR Report Key | 8631816 |
| Report Source | FOREIGN |
| Date Received | 2019-05-22 |
| Date of Report | 2019-05-22 |
| Date of Event | 2016-08-08 |
| Date Mfgr Received | 2019-05-10 |
| Date Added to Maude | 2019-05-22 |
| 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 STACIE-ANN CREIGHTON |
| Manufacturer Street | 1910 E INNOVATION PARK DR NA |
| Manufacturer City | TUSCON AZ 85755 |
| Manufacturer Country | US |
| Manufacturer Postal | 85755 |
| Manufacturer Phone | 9082537112 |
| Manufacturer G1 | NA |
| Manufacturer Street | NA NA |
| Manufacturer City | NA |
| Single Use | 3 |
| Previous Use Code | 3 |
| Removal Correction Number | NA |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | BENCHMARK ULTRA STAINER MODULE |
| Generic Name | SLIDE STAINER, AUTOMATED |
| Product Code | KPA |
| Date Received | 2019-05-22 |
| Model Number | NA |
| Catalog Number | 05342716001 |
| Lot Number | NA |
| Operator | HEALTH PROFESSIONAL |
| 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 DR NA TUCSON AZ 85755 US 85755 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2019-05-22 |