MAUDE Adverse Event Report: INVACARE FLORIDA FULL-ELECTRIC 9153638225; 5410IVC

Model Number NA:5410IVC

Device Problem Use of Device Problem (1670)

Patient Problem Laceration(s) (1946)

Event Type  Injury  

Manufacturer Narrative

Invacare is reporting in an abundance of caution.The care giver stated that there was no malfunction of the bed, the end user pushed so hard on the bed end with their foot that it broke.The user conducted a phone visit with their doctor and is receiving wound care for the alleged injury.No further information concerning the injury, or the treatment could be obtained.

Event Description

The reporter stated the end user was sliding down in the bed and pushed his foot off the foot end panel causing a hole in the panel.He slid back down again and cut a piece of his right hallux off.They stated the toe wasn¿t amputated just a chunk of the side of the toe was cut off.

• Brand Name: FULL-ELECTRIC 9153638225
• Type of Device: 5410IVC
• 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, OH 44035 ; 8003336900
• MDR Report Key: 10180033
• MDR Text Key: 195962004
• Report Number: 1031452-2020-00020
• Device Sequence Number: 1
• Product Code: FNL
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 05/28/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/22/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: NA:5410IVC
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 05/28/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/01/2019
• 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
• Patient Age: 98 YR
• Patient Weight: 73