MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1993-03-09 for UNKNOWN MV300A N/I manufactured by S & S X-ray Products.
[18952573]
It was reported to g. E. That the technologist was attempting to retreive an x-ray and reached down in order to seperate the frames that were below the viewing level. Apparently the tech's foot inadvertly touched the foot pedal, which activated the viewer frames and caused them to move. Allegedly, the tech's third and fourth finger of the left hand were injured, sustaining partial amputationdevice not labeled for single use. Patient medical status prior to event: unknown. There was not multiple patient involvement. Invalid data - on device service/maintenance. No data - regarding date last serviced. Service provided by: invalid data. Invalid data - service records availability. No imminent hazard to public health claimed. Invalid data - whether device used as labeled/intended. Invalid data - regarding evaluation by user after event. Method of evaluation: none or unknown. Results of evaluation: none or unknown. Conclusion: none or unknown. Certainty of device as cause of or contributor to event: unknown (cannot determine). Corrective actions: none or unknown. Invalid data - on device destroyed/disposed of status.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2126677-1993-00001 |
| MDR Report Key | 2584 |
| Date Received | 1993-03-09 |
| Date of Report | 1993-02-05 |
| Date of Event | 1992-03-05 |
| Date Facility Aware | 1992-03-05 |
| Report Date | 1993-02-05 |
| Date Reported to FDA | 1993-02-05 |
| Date Added to Maude | 1993-03-19 |
| Event Key | 0 |
| Report Source Code | Distributor report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 0 |
| Reporter Occupation | UNKNOWN |
| 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 | UNKNOWN |
| Generic Name | X-RAY ILLUMINATOR |
| Product Code | FTG |
| Date Received | 1993-03-09 |
| Model Number | MV300A |
| Catalog Number | N/I |
| Lot Number | N/I |
| ID Number | N/I |
| Operator | OTHER HEALTH CARE PROFESSIONAL |
| Device Availability | * |
| Implant Flag | N |
| Device Sequence No | 1 |
| Device Event Key | 2408 |
| Manufacturer | S & S X-RAY PRODUCTS |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 1993-03-09 |