MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,07 report with the FDA on 2012-03-02 for UMF MEDICAL 5016 manufactured by United Metal Fabricators, Inc..
[18181255]
The chair's leg section was rotated in the out position. Obese pt attempted to access the chair, lost her balance, and hit her calf against the leg section, causing a cut. The pt received stitches to close the cut.
Patient Sequence No: 1, Text Type: D, B5
[18204572]
Images of the leg section were received and evaluated. A repair team was immediately sent to remove any sharp edge. Further action was immediately undertaken to ensure that any potential for a sharp edge was eliminated from the product design.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2518399-2012-00001 |
| MDR Report Key | 2482472 |
| Report Source | 05,07 |
| Date Received | 2012-03-02 |
| Date of Report | 2012-02-02 |
| Date of Event | 2012-02-02 |
| Date Mfgr Received | 2012-02-02 |
| Device Manufacturer Date | 2009-11-01 |
| Date Added to Maude | 2012-03-08 |
| 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 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Street | 1316 EISENHOWER BLVD. |
| Manufacturer City | JOHNSTOWN PA 15904 |
| Manufacturer Country | US |
| Manufacturer Postal | 15904 |
| Manufacturer Phone | 8142668726 |
| Single Use | 3 |
| Remedial Action | RP |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | UMF MEDICAL |
| Generic Name | PODIATRY CHAIR |
| Product Code | INQ |
| Date Received | 2012-03-02 |
| Model Number | 5016 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | UNITED METAL FABRICATORS, INC. |
| Manufacturer Address | JOHNSTOWN PA US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2012-03-02 |