MAUDE Adverse Event Report: KLC, 4038 WEAVER COURT E., HILLIARD, OH 43026 FLEXMATE K500; EXERCISER, POWERED

Device Problem Break (1069)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Type  malfunction  

Event Description

Provider alleges unit is broken and not working.No injury alleged.Invacare prid#: (b)(4).This report reflects information received by fda in the form of a notification per 803.22 (b)(2).

• Brand Name: FLEXMATE K500
• Type of Device: EXERCISER, POWERED
• Manufacturer (Section D): KLC, 4038 WEAVER COURT E., HILLIARD, OH 43026
• MDR Report Key: 17529349
• MDR Text Key: 321411497
• Report Number: MW5136277
• Device Sequence Number: 1
• Product Code: BXB
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 09/14/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/12/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Patient Sequence Number: 1