MAUDE Adverse Event Report: KRUG JORDAN SERIES RECLINER CHAIR; CHAIR, POSITIONING, ELECTRIC

Model Number JORG-SRFUR33

Device Problems Component Missing (2306); Protective Measures Problem (3015)

Patient Problem Laceration(s) (1946)

Event Date 09/01/2021

Event Type  malfunction  

Event Description

Pt.Stood from chair and sustained a cut on his shin due to missing rubber protector on handle.Fda safety report id # (b)(4).

• Brand Name: JORDAN SERIES RECLINER CHAIR
• Type of Device: CHAIR, POSITIONING, ELECTRIC
• Manufacturer (Section D): KRUG; 421 manitou drive; kitchener, ontario N2C1L 5; CA N2C1L5
• MDR Report Key: 12480871
• MDR Text Key: 272127855
• Report Number: MW5103979
• Device Sequence Number: 1
• Product Code: INO
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Type of Report: Initial
• Report Date: 09/13/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/15/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: JORG-SRFUR33
• Was Device Available for Evaluation?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 68 YR
• Patient Weight: 120