inforMED
MalfunctionIOR

WHEELCHAIR

Received Aug 9, 2023

Report MW5121037 · MDR key 17488339

Device

Generic name

Wheelchair, Mechanical

Product problems

  • Defective Component
  • Defective Component

Patient

Unknown

  • No Clinical Signs, Symptoms or Conditions
  • No Clinical Signs, Symptoms or Conditions

Narrative

Description of Event or Problem

STRYKER MEDICAL WAS NOTIFIED OF A POTENTIALLY REPORTABLE COMPLAINT INVOLVING A PRODUCT FOR WHICH STRYKER IS NOT THE ORIGINAL EQUIPMENT MANUFACTURER OF THE REPORTED DEVICE. THE CUSTOMER ALLEGED A MANUFACTURER TRACER WHEELCHAIR SERIAL NUMBER (B)(6), WITH REDUCED BRAKE FORCE. PLEASE FIND ADDITIONAL CONTACT INFORMATION BELOW. (B)(4). THIS REPORT REFLECTS INFORMATION RECEIVED BY FDA IN THE FORM OF A NOTIFICATION PER 803.22 (B)(2).