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

Device Problem Physical Resistance/Sticking (4012)

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

Event Type  malfunction  

Event Description

Hiccups when lowering.No injury alleged invacare (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: 17530911
• MDR Text Key: 321373456
• Report Number: MW5137827
• 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: 07/28/2015

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