MAUDE Adverse Event Report: INVACARE FLORIDA SEMI-ELEC SNGLE CRANK HI/LO 9153638224; BED, THERAPEUTIC, AC-POWERED, ADJUSTABLE HOME-USE

Model Number NA:5310IVC

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem Laceration(s) (1946)

Event Date 08/14/2022

Event Type  Injury  

Manufacturer Narrative

This incident is being reported in an abundance of caution.Further information and a return have been requested but at this time no further information has been obtained.The allegation of a bed rail failing and the user falling couldn¿t be confirmed.The rail model and date/lot code are unknown.At this time, it is unknown if the rails involved are invacare rails.The bed was over 5 years old at the time of this incident.If further information becomes available that changes the current findings a follow up medwatch will be filed.

Event Description

On (b)(6) 2023, a letter was received from an attorney stating ¿the metal railing on the side of the bed failed and the client fell from the bed accordingly.As a result, he injured his knee, head, and arm.He needed 15 stitches in his knee as a result of the lacerations that he suffered.".

• Brand Name: SEMI-ELEC SNGLE CRANK HI/LO 9153638224
• Type of Device: BED, THERAPEUTIC, AC-POWERED, ADJUSTABLE HOME-USE
• Manufacturer (Section D): INVACARE FLORIDA; 2101 east lake mary blvd; sanford FL 32773
• Manufacturer (Section G): INVACARE FLORIDA; 2101 east lake mary blvd; sanford FL 32773
• Manufacturer Contact: jason fiest ; one invacare way; elyria 44035 ; 8003336900
• MDR Report Key: 16944828
• MDR Text Key: 315358563
• Report Number: 1031452-2023-00016
• Device Sequence Number: 1
• Product Code: LLI
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 05/11/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/17/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: NA:5310IVC
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 04/18/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/01/2017
• 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): Required Intervention