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Medical Devices / Inspections and Audits

Australian Wheelchair Manufacturer Failed to Report Product Defects

Sept. 5, 2018

Magic Mobility was called out by the FDA and issued a Form 483 over MDR reporting and complaint handling practices at its Melbourne facility, including a failure to report a serious wheelchair malfunction.

The investigator, who inspected the facility in late October, found that the firm had no MDR procedures. Despite receiving information that warranted an MDR report, the firm did not submit one within the 30 day deadline. Specifically, it received a claim that its Extreme X8 wheelchair emitted a burning smell and smoke from under the seat while being driven, launching the user out of the chair when the joystick wire flared up.

The agency also found the firm did not have a proper complaint procedure to describe how to routinely and quickly process complaints, maintain complaint files, receive, review and evaluate complaints and evaluate the reportability of complaints.

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