MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06 report with the FDA on 2014-08-01 for OMNICYCLE ELITE A000-533 NA manufactured by Medica Medizintechnik Gmbh.
[19590968]
On (b)(6) 2014 acp was notified of event. Pt was in a wheelchair with her right leg in an extension brace, which needed to be elevated. The therapist removed the right pedal of the omnicycle and placed the pt in front of the cycle to utilize her left side for exercise. Approximately two minutes into the exercise, the pt reported that her leg felt heavy. The therapist noticed blood on the floor. The pt was left unattended. The pt sustained a 5 inch laceration on her right calf which required 18 stitches.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1911273-2014-00003 |
| MDR Report Key | 4003219 |
| Report Source | 06 |
| Date Received | 2014-08-01 |
| Date of Report | 2014-07-31 |
| Date of Event | 2014-07-16 |
| Date Facility Aware | 2014-07-17 |
| Report Date | 2014-07-29 |
| Date Reported to FDA | 2014-07-31 |
| Date Reported to Mfgr | 2014-07-31 |
| Device Manufacturer Date | 2010-12-10 |
| Date Added to Maude | 2014-08-13 |
| 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 | 2014-08-01 |
| Model Number | A000-533 |
| Catalog Number | NA |
| Lot Number | NA |
| ID Number | A0005330310493088 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | 4 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 | 2014-08-01 |