ROHO AIR CUSHIONS

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2015-06-24 for ROHO AIR CUSHIONS manufactured by The Roho Group.

Event Text Entries

[16543202] After my 1997 high profile roho cushion went out in (b)(6) 2013, i switched to a 2006 high profile cushion which caused me diaphragmatic pain and restricted my arms mobility. In april 2014, when i switched to a current high profile roho cushion, i turned blue because of lack of oxygen because the new material and design caused me to immerse almost to the bottom on regular inflation, which made my breathing muscles collapse. Inflating it more to prevent immersion caused me skin sores and diaphragmatic pain. The new design also prevented me from moving my arms as much as i used to on my 1997 cushion. I then tried a high profile roho qs and a low profile which had the same effects because they have the same material and design. In the (b)(6) of 2014, my medical team reports described the life-threatening breathing-related symptoms i had on current roho cushions and requested the roho group to replicate my 1997 cushion. Roho refused, and they also denied subsequent requests to allow me to finance their research to recreate this product. Since then, i have been surviving on 1990s cushions i purchased on -(b)(6), which enable me to breathe because they are made of the right material, but unfortunately they are not the size i need, so my range of movement is still restricted, which makes it difficult to feed myself and drive. There is no other product on the market today that would meet my needs. Several other roho customers have been complaining about the thin material currently used in their cushions, which caused them serious health issues (b)(6). I am an (b)(6), and i run a non-profit organization and a translations agency. The fact that the roho group produces new cushions that hinder my breathing, driving, and self-care and professional activities is not only life-threatening to me, but also harms all people and activities with which i am involved. This situation has been already mediatized worldwide. I trust you that you will take action that will require the roho group to revise their current design and chemical formulation and resume the 1997 design and formulation that did not cause life-threatening side effects. New roho cushions design and material are hindering my breathing and my arms movement range.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: MW5043281
• MDR Report Key: 4875250
• Date Received: 2015-06-24
• Date of Report: 2015-06-15
• Date of Event: 2013-06-01
• Date Added to Maude: 2015-06-30
• Event Key: 0
• Report Source Code: Voluntary report
• Manufacturer Link: N
• Number of Patients in Event: 0
• Adverse Event Flag: 3
• Product Problem Flag: 3
• Reprocessed and Reused Flag: 0
• Reporter Occupation: PATIENT
• Health Professional: 0
• Initial Report to FDA: 3
• Report to FDA: 0
• Event Location: 0
• Single Use: 0
• Previous Use Code: 0
• Event Type: 3
• Type of Report: 3

Device Sequence Number: 1

• Brand Name: ROHO AIR CUSHIONS
• Generic Name: HIGH PROFILE
• Product Code: KIC
• Date Received: 2015-06-24
• Operator: LAY USER/PATIENT
• Device Availability: N
• Device Sequence No: 1
• Device Event Key: 0
• Manufacturer: THE ROHO GROUP

Device Sequence Number: 2

• Brand Name: ROHO AIR CUSHIONS
• Generic Name: LOW PROFILE
• Product Code: KIC
• Date Received: 2015-06-24
• Operator: LAY USER/PATIENT
• Device Availability: N
• Device Sequence No: 2
• Device Event Key: 0
• Manufacturer: THE ROHO GROUP

Device Sequence Number: 3

• Brand Name: ROHO AIR CUSHION
• Generic Name: QUADTRO SELECT
• Product Code: KIC
• Date Received: 2015-06-24
• Operator: LAY USER/PATIENT
• Device Availability: N
• Device Sequence No: 3
• Device Event Key: 0
• Manufacturer: THE ROHO GROUP

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Life Threatening; 2. Other; 3. Deathisabilit	2015-06-24