MAUDE Adverse Event Report: HOCOMA AG LOKOMAT PRO; ISOKINETIC TESTING AND EVALUATION SYSTEM

Device Problem Patient-Device Incompatibility (2682)

Patient Problems Bruise/Contusion (1754); Tissue Damage (2104); Pressure Sores (2326)

Event Date 07/17/2012

Event Type  Injury  

Event Description

Mr lb reported that he had attended 2 or 3 sessions on the lokomat and had developed serious grade 4 pressure ulcers as a result.Preliminary note: the patient usually lives in a different part of the world where he does his regular lokomat training sessions 3 times a week for 1 hour.No adverse events have happened during these regular sessions.For the time the patient spent in l., he referred to an outpatient department to continue his regular training sessions with the device in place.Three lokomat training sessions were conducted in the above-mentioned outpatient department: - (b)(6) 2017: initial assessment.- (b)(6) 2017 50 min lokomat training.- (b)(6) 2017 17 min lokomat training.The patient reported to the initial reporter that he had attended an initial appointment for assessment and had then agreed to attend the [2nd] training session.He reported that he attended the training session which was around an hour which is no more than he normally does at home and that the third session was much shorter.Mr lb reported that following the training session, his nurse had noticed 2 small "bruises" on his buttocks and that he went to see his gp who did not think there was anything wrong.He then attended his third lokomat session with the therapist and reported the pressure problems on the ankles.Mr lb reported that unbeknown to him or us there was tissue damage beneath the small bruised area that he feels must have been caused during the training session either by the straps being too tight or too loose or the padding not being in place.

• Brand Name: LOKOMAT PRO
• Type of Device: ISOKINETIC TESTING AND EVALUATION SYSTEM
• Manufacturer (Section D): HOCOMA AG; industriestrasse 4; volketswil, CH-86 04; SZ CH-8604
• Manufacturer (Section G): HOCOMA AG; industriestrasse 4; volketswil, CH-86 04; SZ CH-8604
• Manufacturer Contact: kevin walls ; 33 golden eagle lane; littleton, CO 80127 ; 7209625412
• MDR Report Key: 7073720
• MDR Text Key: 93421422
• Report Number: 3003781275-2017-00001
• Device Sequence Number: 1
• Product Code: IKK
• Combination Product (y/n): N
• Reporter Country Code: UK
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 11/30/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/30/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 10/16/2012
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/13/2011
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 59 YR
• Patient Weight: 68