MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a distributor,foreign report with the FDA on 2016-09-09 for ROHO? AIRLITE? CUSHION manufactured by Roho, Inc..
[54397603]
Roho conducted an investigation into this event. Our distributor was unable to obtain the airlite cushion serial number, model number, size, or sell date from the customer. The cushion has not been returned to the distributor or to roho for evaluation. We have provided an image of the label placed on the outside of airlite cushions, showing how the cushion should be placed in the wheelchair along with the product operation manual, which explains how to properly place the cushion in the wheelchair. Roho's distributor also provided the following information: the leader of the depot in (b)(4) gave us permission to write in the report that he confirms that all roho cushions are labeled correctly regarding how to place it in the wheelchair and it is always delivered with a user manual. His name is (b)(4). (b)(4) stated the caretakers do not read the labels or the user manual and that is why the event happened. The depot admitted that there is nothing wrong with the airlite cushion and that they have placed it incorrectly in the wheelchair.
Patient Sequence No: 1, Text Type: N, H10
[54397604]
Roho was informed by our distributor that a customer developed a pressure injury after sitting on an airlite cushion that had been placed in the wheelchair backwards (front of cushion was in the back of the chair). Our distributor was also told that the cushion was being used at home after it was placed in the wheelchair by a caretaker and that the pressure injury was severe enough to see the patient's bone. Our distributor was told that surgery was not needed on the injury and that the patient has been in bed. No other information was available on details of the event or the patient's condition (e. G. How long the cushion was used in the incorrect orientation, if there were any pre-existing injuries or conditions that could have contributed to this event, etc. ).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1419507-2016-00004 |
| MDR Report Key | 5940601 |
| Report Source | DISTRIBUTOR,FOREIGN |
| Date Received | 2016-09-09 |
| Date of Report | 2016-09-08 |
| Date Mfgr Received | 2016-08-30 |
| Date Added to Maude | 2016-09-09 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MS. ROBIN GERGEN |
| Manufacturer Street | 100 N. FLORIDA AVE. |
| Manufacturer City | BELLEVILLE IL 62221 |
| Manufacturer Country | US |
| Manufacturer Postal | 62221 |
| Manufacturer Phone | 8003562990 |
| Manufacturer G1 | ROHO, INC. |
| Manufacturer Street | 100 N. FLORIDA AVE. |
| Manufacturer City | BELLEVILLE IL 62221 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 62221 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ROHO? AIRLITE? CUSHION |
| Generic Name | CUSHION, FLOTATION |
| Product Code | KIC |
| Date Received | 2016-09-09 |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ROHO, INC. |
| Manufacturer Address | 100 N. FLORIDA AVE. BELLEVILLE IL 62221 US 62221 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2016-09-09 |