MAUDE Adverse Event Report: R82 A/S R82; CROCODILE GAIT TRAINER

Model Number	CROCODILE GAIT TRAINER SIZE 2
Medical Device Problem Code	Mechanical Problem (1384)
Health Effect - Clinical Code	Fall (1848)
Date of Event	03/09/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
The end user's mother claims that the waist belt snapped off while he was walking.While walking, the waist belt snapped off and he fell face first onto concrete.He lost a tooth and may need stitches in his lip.Need to see dentist and there is a concern that it may have damaged his permanent teeth.
Additional Manufacturer Narrative
Based on pictures of the device involved in the incident it is concluded that the incident was caused by insufficient inspection of the device before according to user manual.Text in user manual: " carry out all positional adjustments on the product and accessories and ensure that all knobs, screws and buckles are securely fastened before use".For investigation see additional comments section b.The device has not been received for investigation and therefore an investigation has not been possible to perform on the involved device.Similar devices on stock has been investigated regarding quality of thread in the surrounding support belt concluding that these are valid and according to specifications.It is therefore concluded that the root cause is failure to follow instructions as described in the user manual: "carry out all positional adjustments on the product and accessories and ensure that all knobs, screws and buckles are securely fastened before use".During investigation it is concluded that the bolt needs to be rotated 5 times before detachment and after 1 rotation the belt will become loose/woobly and therefore detectable and should have been re tightened before use according to instruction.Furthermore the accessory surrounding support has been on the market for several years with thousands of accessories on the market and this is the first case we have seen with this issue.It is therefore concluded that the risk assessment is still valid and the device/accessory is safe to use.

• Brand Name: R82
• Common Device Name: CROCODILE GAIT TRAINER
• Manufacturer (Section D): R82 A/S; parallelvej 3; gedved, ; DA
• Manufacturer Contact: claus riis ; parallelvej 3; gedved, ; DA
• MDR Report Key: 24714253
• Report Number: 3001657382-2026-00001
• Device Sequence Number: 14893730
• Product Code: ITJ
• UDI-Device Identifier: 05707292355959
• UDI-Public: 05707292355959
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 03/26/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Lay User/Patient
• Device Model Number: CROCODILE GAIT TRAINER SIZE 2
• Device Catalogue Number: 86802
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/11/2026
• Initial Report FDA Received Date: 03/30/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/27/2025
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: USED WITH ACCESSORY SURROUNDING SUPPORT 868610-2M
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 2 MO
• Patient Sex: Male
• Patient Weight: 21 KG