MAUDE Adverse Event Report: MEDICA MEDIZINTECHNIK GMBH OMNICYCLE POWERED THERAPY BICYCLE; EXERCISER, POWERED

Model Number A000-533

Patient Problems Hemorrhage/Bleeding (1888); Unspecified Tissue Injury (4559)

Event Date 07/26/2023

Event Type  Injury  

Event Description

Therapist started off treatment with setting patient up on the omnicycle.The velcro foot straps that are standard issue with the omnicycle had been removed and were not present for this treatment.The therapist strapped the patient to the pedal by wrapping theraband around the foot pedal and the patient's forefoot.The standard-issue calf pad had also been removed and was not being used with this treatment.Once patient was set up on oc by therapist, the therapist checked with the patient to confirm no adjustments needed to be made, such as bringing patient closer to cycle, then patient confirmed they were ready to start exercise.Therapist then started the treatment.Omnicycle was on lower extremity exercise on assisted mode in ortho.Resistance was set to 4 but speed is unknown by therapist.Within first 2 minutes of start of exercise, the patient's foot slipped off the cycle and foot pedal hit the patient's shin.Therapist heard patient say "ow" right after so he stopped the exercise and took patient off oc.Therapist propped the patient's foot on a stool and noticed some bleeding.He alerted another therapist of issue to get help.The facility called the ambulance and the medics wrapped the leg up.Therapist says patient stayed overnight at hospital and was released next day.Patient had 4-6 inch cut and is currently being seen by a wound clinic.Update on (b)(6) 2023: the wound is healing.From the comments provided by the facility, it's clear that the equipment was not set up to our recommendations.A calf pad was not present or used, and the facility did not have foot straps.Both of those items are readily available by overnight shipment.The velcro straps were in the therapy closed, but theraband was used instead.

• Brand Name: OMNICYCLE POWERED THERAPY BICYCLE
• Type of Device: EXERCISER, POWERED
• Manufacturer (Section D): MEDICA MEDIZINTECHNIK GMBH
• MDR Report Key: 17691940
• MDR Text Key: 322926333
• Report Number: MW5145207
• Device Sequence Number: 1
• Product Code: BXB
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date: 08/30/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/05/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: A000-533
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization