MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-01-29 for OMNICYCLE A000-533 manufactured by Medica Medizintechnik Gmbh.
[37735388]
Therapist placed pt on cycle, calf pad was not on the calf support. Upper extremity exercise was planned, but was not selected. Cycle started in lower exercise causing a laceration to pt's shin. The pt was sent to the emergency room and required stitches.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1911273-2016-00001 |
| MDR Report Key | 5416286 |
| Date Received | 2016-01-29 |
| Date of Report | 2016-01-28 |
| Date of Event | 2015-12-29 |
| Date Facility Aware | 2015-12-29 |
| Report Date | 2016-01-29 |
| Date Reported to FDA | 2016-01-29 |
| Date Reported to Mfgr | 2016-01-29 |
| Date Added to Maude | 2016-02-08 |
| 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 | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Street | 4850 JOULE STREET, BLDG. A-1 |
| Manufacturer City | RENO NV 89502 |
| Manufacturer Country | US |
| Manufacturer Postal | 89502 |
| Manufacturer G1 | ACCELERATED CARE PLUS CORP. |
| Manufacturer Street | 4850 JOULE STREET, BLDG. A-1 |
| Manufacturer City | RENO NV 89502 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 89502 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | OMNICYCLE |
| Generic Name | EXERCISER, POWERED |
| Product Code | BXB |
| Date Received | 2016-01-29 |
| Model Number | A000-533 |
| Lot Number | 08 |
| ID Number | A0005330813244024 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | 3 YR |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MEDICA MEDIZINTECHNIK GMBH |
| Manufacturer Address | BLUMENWEG 8 HOCKDORF D-88454 GM D-88454 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2016-01-29 |