MAUDE Adverse Event Report: R82 A/S FLAMINGO

Model Number 8805503

Device Problem Use of Device Problem (1670)

Patient Problem Bone Fracture(s) (1870)

Event Date 02/12/2021

Event Type  Injury  

Manufacturer Narrative

The incident occurred as the user leant forward after the helper had loosened both the h-chest belt and the hip belt.As a consequence the user's full weight was pushing out against the swing-away arm support that is designed for supporting the arms in a seated position.The break of the holder arose due to the excessive body load put on the arm support.Strength of bracket tested in product test (according to en 12182).No similar cases since launch in 1999.Based on the patient's disability, the rehabilitation process will be much more difficult compared to a child of the same age without disability.The patient is at a very low level.Will be difficult to train and difficult to understand recommendations afterwards, such as step marking / what load may be placed on the leg.Already before the case had difficulty supporting the leg, unclear why, have waited for x-ray time.

Event Description

The patient has fallen from his hygiene chair which was fixed on the toilet in the home and in the case broke his leg.The case occurred when the parent / assistant unbuttoned the patient's h-harness and hip belt to dry after a toilet visit and the patient then leaned with a large part of the body weight over the forearm supports which gave way and came loose.

• Brand Name: FLAMINGO
• Type of Device: FLAMINGO
• Manufacturer (Section D): R82 A/S; parallelvej 3; gedved, 8751 ; DA 8751
• Manufacturer (Section G): R82 A/S; parallelvej 3; gedved, 8751 ; DA 8751
• Manufacturer Contact: mogens rahbek ; parallelvej 3; gedved, 8751 ; DA 8751
• MDR Report Key: 11541990
• MDR Text Key: 241445666
• Report Number: 3001657382-2021-00002
• Device Sequence Number: 1
• Product Code: INM
• Combination Product (y/n): N
• Reporter Country Code: SW
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign
• Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date: 03/22/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/22/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Other
• Device Model Number: 8805503
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 02/26/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/17/2020
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization