MAUDE Adverse Event Report: EZ WAY, INC. EZ WAY REGULAR (BASIC) SLING; AID, TRANSFER

Catalog Number 50311

Device Problems Adverse Event Without Identified Device or Use Problem (2993); Patient Device Interaction Problem (4001)

Patient Problem Fall (1848)

Event Date 06/21/2023

Event Type  Injury  

Event Description

Sling and ez lift were connected and used appropriately and according to manufacturer guidelines to lift resident with 2 staff.Resident was within the weight recommendation for a medium sling; however, she suddenly shifted her weight slipped out the side of the sling while it remained attached to the lift stand.

• Brand Name: EZ WAY REGULAR (BASIC) SLING
• Type of Device: AID, TRANSFER
• Manufacturer (Section D): EZ WAY, INC.
• MDR Report Key: 17248204
• MDR Text Key: 318358396
• Report Number: MW5119060
• Device Sequence Number: 1
• Product Code: IKX
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date: 06/28/2023

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 Catalogue Number: 50311
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 06/30/2023
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Disability
• Patient Age: 103 YR
• Patient Sex: Female
• Patient Weight: 60 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White