MAUDE Adverse Event Report: INVACARE CORP. INVACARE; INVACARE HOYER SLING

Model Number R111

Device Problem Torn Material (3024)

Patient Problem Fall (1848)

Event Date 09/11/2017

Event Type  Injury  

Event Description

Resident was being transferred when sling tore causing resident to fall to floor.

• Brand Name: INVACARE
• Type of Device: INVACARE HOYER SLING
• Manufacturer (Section D): INVACARE CORP.; 39400 taylor parkway; north ridgeville OH 44039
• MDR Report Key: 7544235
• MDR Text Key: 109451464
• Report Number: MW5077448
• Device Sequence Number: 1
• Product Code: FNG
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 09/19/2017

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: Health Professional
• Device Model Number: R111
• Device Catalogue Number: R111
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 05/24/2018
• 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): Hospitalization; Other
• Patient Age: 88 YR
• Patient Weight: 97