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

Model Number A000-533

Device Problem Mechanics Altered (2984)

Patient Problem Laceration(s) (1946)

Event Date 12/29/2015

Event Type  Injury  

Event Description

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.

• Brand Name: OMNICYCLE
• Type of Device: EXERCISER, POWERED
• Manufacturer (Section D): MEDICA MEDIZINTECHNIK GMBH; blumenweg 8 ; hockdorf D-884 54; GM D-88454
• Manufacturer (Section G): ACCELERATED CARE PLUS CORP.; 4850 joule street, bldg. a-1; reno NV 89502
• Manufacturer Contact: 4850 joule street, bldg. a-1; reno, NV 89502
• MDR Report Key: 5416286
• MDR Text Key: 37735388
• Report Number: 1911273-2016-00001
• Device Sequence Number: 1
• Product Code: BXB
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 01/29/2016,01/28/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/29/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: A000-533
• Device Lot Number: 08
• Other Device ID Number: A0005330813244024
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 01/29/2016
• Distributor Facility Aware Date: 12/29/2015
• Device Age: 3 YR
• Event Location: Outpatient Treatment Facility
• Date Report to Manufacturer: 01/29/2016
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other