MAUDE Adverse Event Report: INVACARE TAYLOR STREET NLA HYDRAULIC LIFT W/ADJ BASE-PLUS 9153633522; LIFT, PATIENT, AC-POWERED

Model Number NA:RHA450-1

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Laceration(s) (1946)

Event Date 03/11/2019

Event Type  Injury  

Manufacturer Narrative

Invacare is filing this record in an abundance of caution.The patients husband included pictures with his notification.The first picture shows what appears to be a large laceration, there is nothing in the picture to assist in accurately judging size.The second picture shows the control handle.The control handle does not appear to have any deficiencies, nor are there any allegations of malfunction.The reported issue has not been verified, and the underlying cause cannot be definitively determined.The most probable cause is the patient hit her leg on the control handle with increased force from a spasmodic jerk caused by the tone in her r.Leg.Invacare requested the return of the lift.The husband declined to return to the lift stating it was functioning fine and he needs it to transport his wife.He said that he will try and return the pump in a couple of months.Should additional information become available, a supplemental record will be filed.

Event Description

The end user¿s husband alleges the end user obtained a laceration to her shin while she was being raised on the rha450-1 lift.He relates the end user has a lot of tone in her right leg.The end user¿s right toe got caught underneath the bottom of the pump handle and her leg came up forcibly and hit the bottom edge of the control handle causing a laceration to the shin.He stated that the end user has thin skin.No medical attention was sought, the laceration was treated by the husband with sterile strips.

• Brand Name: NLA HYDRAULIC LIFT W/ADJ BASE-PLUS 9153633522
• Type of Device: LIFT, PATIENT, AC-POWERED
• Manufacturer (Section D): INVACARE TAYLOR STREET; 1200 taylor street; elyria OH 44036
• Manufacturer (Section G): INVACARE TAYLOR STREET; 1200 taylor street; elyria OH 44036
• Manufacturer Contact: jason fiest ; one invacare way; elyria, OH 44035 ; 8003336900
• MDR Report Key: 8504787
• MDR Text Key: 141624450
• Report Number: 1525712-2019-00008
• 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: Manufacturer
• Source Type: consumer
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 03/13/2019

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: Other
• Device Model Number: NA:RHA450-1
• Device Catalogue Number: RHA450-1
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 03/13/2019
• Initial Date FDA Received: 04/11/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/01/2006
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 67 YR