MAUDE Adverse Event Report: GOLDEN TECHNOLOGIES, INC. GOLDEN PR515 MLA MAXICOMFORT CLOUD WITH TWILIGHT ZERO GRAVITY LIFT CHAIR; CHAIR, POSITIONING, ELECTRIC

Model Number PR515-SME-STD-D10

Device Problem Positioning Problem (3009)

Patient Problem Nerve Damage (1979)

Event Date 05/03/2022

Event Type  Injury  

Event Description

End user was in the reclined position, she tried to have the chair lift her up, but it would not move and her shoulders back nerves pinched so severely she had to call 911, and was taken to the hospital because she could not move.Fda safety report id# (b)(4).

• Brand Name: GOLDEN PR515 MLA MAXICOMFORT CLOUD WITH TWILIGHT ZERO GRAVITY LIFT CHAIR
• Type of Device: CHAIR, POSITIONING, ELECTRIC
• Manufacturer (Section D): GOLDEN TECHNOLOGIES, INC.; old forge PA 18518
• MDR Report Key: 14855700
• MDR Text Key: 295067518
• Report Number: MW5110596
• Device Sequence Number: 1
• Product Code: INO
• 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
• Report Date: 06/27/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/28/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Model Number: PR515-SME-STD-D10
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/10/2022
• Is the Reporter a Health Professional?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization