MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2015-06-09 for RELIANCE CART AND UTENSIL WASHER/DISINFECTOR 1227 FW03-101 N/A manufactured by Steris.
[5805774]
Employees are sustaining hand injuries when removing carts from the cart washer. Their hands are getting caught between the cart and door when unloading. No handles are attached.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 4852674 |
| MDR Report Key | 4852674 |
| Date Received | 2015-06-09 |
| Date of Report | 2015-06-09 |
| Date of Event | 2015-06-05 |
| Report Date | 2015-06-09 |
| Date Reported to FDA | 2015-06-09 |
| Date Reported to Mfgr | 2015-06-18 |
| Date Added to Maude | 2015-06-18 |
| 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 | 3 |
| 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 | RELIANCE CART AND UTENSIL WASHER/DISINFECTOR |
| Generic Name | WASHER OF BODY WASTE RECEPTACLES |
| Product Code | FLH |
| Date Received | 2015-06-09 |
| Model Number | 1227 FW03-101 |
| Catalog Number | N/A |
| Lot Number | N/A |
| ID Number | * |
| Operator | OTHER |
| Device Availability | * |
| Device Age | 1 YR |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | STERIS |
| Manufacturer Address | 5960 HEISLEY ROAD MENTON OH 44060 US 44060 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2015-06-09 |