MAUDE Adverse Event Report: LA-Z-BOY LA-Z-BOY; BARIATRIC RECLINER CHAIR

Model Number HARMONY

Device Problems Sticking (1597); Use of Device Problem (1670)

Patient Problem Pain (1994)

Event Date 07/10/2016

Event Type  malfunction  

Event Description

While the foot rest was extended, the pt's right foot slipped underneath the metal has between the chair seat and foot rest pad on the recliner chair and became stuck.The nurse tried to remove the foot using lotion to lubricate the area but was unsuccessful.Pt was medicated for pain.Fire department/ems personnel responded.They partially cut through the metal frame and were able to release the foot.No immediate skin abnormalities noted.Pt received an x-ray, which came back negative.The foot was noted to be smaller than average.(b)(6).

• Brand Name: LA-Z-BOY
• Type of Device: BARIATRIC RECLINER CHAIR
• Manufacturer (Section D): LA-Z-BOY; 1790 dixwell ave; hamden CT 06514
• MDR Report Key: 5892915
• MDR Text Key: 52767066
• Report Number: MW5064203
• Device Sequence Number: 1
• Product Code: INN
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial
• Report Date: 08/02/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: HARMONY
• Device Lot Number: 696005
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/18/2016
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 86 YR
• Patient Weight: 53