MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2015-02-05 for UMF MEDICAL 4070 * manufactured by United Metal Fabricators, Inc..
[19091596]
The patient was in a room for a visit with the physician (md), and she stood on the height adjustment pedal (patient was "playing" with equipment) that was placed on chassis table platform of exam table. As the body of the exam table came down, it trapped her foot on the "down" pedal in between the chassis platform and the body of the exam table. The "up" height adjustment was non-functional while the "down" pedal was being pressed (involuntarily since her foot was trapped on it). The nurse (rn) was able to pry the pedal from under the patient's foot and engage the "up" pedal to release the patient's right foot. Swelling was noted and a contusion. There was no broken skin. The patient was sent to imaging for an x-ray of her foot. Impression of the x-ray finding: soft tissue of mid-foot. No fracture or dislocation.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 4530610 |
| MDR Report Key | 4530610 |
| Date Received | 2015-02-05 |
| Date of Report | 2015-02-05 |
| Date of Event | 2014-11-12 |
| Report Date | 2015-02-05 |
| Date Reported to FDA | 2015-02-05 |
| Date Reported to Mfgr | 2015-02-20 |
| Date Added to Maude | 2015-02-20 |
| 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 | 0 |
| 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 | UMF MEDICAL |
| Generic Name | TABLE, POWERED |
| Product Code | INQ |
| Date Received | 2015-02-05 |
| Model Number | 4070 |
| Catalog Number | * |
| Lot Number | * |
| ID Number | * |
| Operator | PATIENT |
| Device Availability | Y |
| Device Age | 1 YR |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | UNITED METAL FABRICATORS, INC. |
| Manufacturer Address | 1316 EISENHOWER BOULEVARD JOHNSTOWN PA 15904339 US 15904 3393 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2015-02-05 |