MAUDE Adverse Event Report: KNU, LLC RECLINER CHAIR; CHAIR AND TABLE, MEDICAL

Model Number 1207791-009.113

Device Problem Mechanical Problem (1384)

Patient Problem Abrasion (1689)

Event Date 09/03/2020

Event Type  Injury  

Event Description

Rn entered room to find patient yelling for help because the patients bka was stuck between the slot in the chair.Maintenance was called to the scene to remove part of the leg of the chair for easier removal with no success because patients leg was stuck between the metal part that attaches the leg of the chair.Patient was able to wiggle his leg out from the metal after a few minutes with no other intervention.Open abrasion was noted upon removal of limb.Fda safety report id # (b)(4).

• Brand Name: RECLINER CHAIR
• Type of Device: CHAIR AND TABLE, MEDICAL
• Manufacturer (Section D): KNU, LLC; ferdinand
• MDR Report Key: 10967343
• MDR Text Key: 220522807
• Report Number: MW5098248
• Device Sequence Number: 1
• Product Code: KMN
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 12/04/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 1207791-009.113
• Device Lot Number: 3146004(LOAD#)
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 12/07/2020
• 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 Outcome(s): Required Intervention
• Patient Age: 63 YR