MAUDE Adverse Event Report: UNKNOWN WALKER; WALKER, MECHANICAL

Device Problem Manufacturing, Packaging or Shipping Problem (2975)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 06/06/2019

Event Type  No Answer Provided  

Event Description

Power chairs need lights and signal turn indicators for public and personal safety like even for bicycles and scooters.All power chairs and some walker and wheel chairs with no light or turning signals are unsafe, period.In the united states, amber front and red rear side marker lamps and retroflectors are required.The law initially required lights or retroreflectors on vehicles manufactured after 1 january 1968.This was amended to require lights and retroflectors on vehicles manufactured after 1 january 1970.Retailer: all.Retailer state: all medical supply stores.(b)(4).

• Brand Name: WALKER
• Type of Device: WALKER, MECHANICAL
• Manufacturer (Section D): UNKNOWN
• MDR Report Key: 8838764
• MDR Text Key: 152803603
• Report Number: MW5088460
• Device Sequence Number: 2
• Product Code: ITJ
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Unknown
• Type of Report: Initial
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 07/26/2019
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1