MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06 report with the FDA on 2014-06-10 for OMNICYCLE ELITE A000-533 NA manufactured by Medica Medizintechnik Gmbh.
[4569893]
Patient was pedaling using lower extremity exerciser on the omnicycle. Patient's left pant leg got caught in crank arm which twisted pants around patient's leg. No one had noticed the pants being twisted around patient's leg until the patient cried out. Therapist then pushed the stop button to stop session. Patient incurred bruising and after continued swelling, and was sent for x-ray. The first viewing of x-ray was reported as an old fracture anterior tibia, second viewing of x-ray was reported as a new fracture. Patient has diagnosis history of osteoporosis.
Patient Sequence No: 1, Text Type: D, B5
[12081747]
On (b)(6) 2014 accelerated care plus (distributor) staff took pictures of the omnicycle after the event. The cycle's left and right side calf support and velcro straps were not attached, and the right side calf support bar was detached from foot pedal. The first viewing of x-ray was reported as an old fracture anterior tibia, second viewing of x-ray was reported as a new fracture. The patient is confirmed as having existing osteoporosis.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1911273-2014-00002 |
| MDR Report Key | 3879533 |
| Report Source | 06 |
| Date Received | 2014-06-10 |
| Date of Report | 2014-05-23 |
| Date of Event | 2014-05-12 |
| Date Facility Aware | 2014-05-16 |
| Report Date | 2014-05-23 |
| Date Mfgr Received | 2014-05-16 |
| Device Manufacturer Date | 2011-03-30 |
| Date Added to Maude | 2014-06-18 |
| 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 |
| Reporter Occupation | BIOMEDICAL ENGINEER |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Street | BLUMENWEG 8 |
| Manufacturer City | HOCKDORF D-88454 |
| Manufacturer Country | GM |
| Manufacturer Postal | D-88454 |
| Manufacturer Phone | 35593140 |
| Single Use | 3 |
| Remedial Action | RL |
| Previous Use Code | 3 |
| Removal Correction Number | NA |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | OMNICYCLE ELITE |
| Generic Name | EXERCISER, POWERED |
| Product Code | BXB |
| Date Received | 2014-06-10 |
| Returned To Mfg | 2014-05-19 |
| Model Number | A000-533 |
| Catalog Number | NA |
| Lot Number | NA |
| ID Number | A0005330311131064 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | 3 YR |
| Device Eval'ed by Mfgr | R |
| 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. Required No Informationntervention | 2014-06-10 |