LOKOMAT PRO

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-11-30 for LOKOMAT PRO manufactured by Hocoma Ag.

Event Text Entries

[93421422] 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.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number3003781275-2017-00001
MDR Report Key7073720
Date Received2017-11-30
Date of Report2017-11-30
Date of Event2012-07-17
Date Mfgr Received2012-10-16
Device Manufacturer Date2011-10-13
Date Added to Maude2017-11-30
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Manufacturer ContactMR. KEVIN WALLS
Manufacturer Street33 GOLDEN EAGLE LANE
Manufacturer CityLITTLETON CO 80127
Manufacturer CountryUS
Manufacturer Postal80127
Manufacturer Phone7209625412
Manufacturer G1HOCOMA AG
Manufacturer StreetINDUSTRIESTRASSE 4
Manufacturer CityVOLKETSWIL, CH-8604
Manufacturer CountrySZ
Manufacturer Postal CodeCH-8604
Single Use3
Previous Use Code3
Event Type3
Type of Report0

Device Details

Brand NameLOKOMAT PRO
Generic NameISOKINETIC TESTING AND EVALUATION SYSTEM
Product CodeIKK
Date Received2017-11-30
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerHOCOMA AG
Manufacturer AddressINDUSTRIESTRASSE 4 VOLKETSWIL, CH-8604 SZ CH-8604


Patients

Patient NumberTreatmentOutcomeDate
101. Other 2017-11-30

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