MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a consumer report with the FDA on 2019-01-02 for ROHO? QUADTRO SELECT? HIGH PROFILE? CUSHION QS910C manufactured by Roho, Inc..
[131889102]
The end user's wife called on behalf of her husband regarding an unrelated concern that did not contribute to the alleged injury. While speaking to her, it was mentioned that the end user has a history of obtaining pressure sores which is why he was given a roho cushion. She states the roho cushion was used for about 2-3 months before the second sore was noticed. Prior to receiving a roho, the patient had been seeing a general surgeon and multiple attempts were made to debride unrelated wounds. These attempts were not effective, and the originating wound was just getting bigger. She mentioned that when the roho cushion was received the end user was sitting on top of the cushion, not immersed. They saw a seating specialist that advised them that they were using the cushion inappropriately and educated them on the proper way to set-up the cushion for operation. At some point while using the cushion, the patient developed a second pressure sore. The wife believes that this was due to the heat being trapped under her husband's bottom while using the roho cushion. A replacement cushion was sent to the caller and a return label was given so that the cushion of concern could be evaluated. However, the product has not been returned yet, so an evaluation could not be conducted at this time. Subsequent check-ins with the caller have all returned positive progress notes. The end user had a routine check-up with his physician where he was instructed to continue hyperbaric treatment paired with getting off his roho cushion and resting throughout the day. At the time of reporting, the end user had no hospitalizations and was not required to seek additional medical attention outside of what was already scheduled. Case is being reported as a precaution due to the allegation of an injury. Although an alleged injury is reported, no medical documents have been submitted for confirmation. If additional information is presented by the evaluation of returned product or additional contact with the end user, a follow up report will be submitted.
Patient Sequence No: 1, Text Type: N, H10
[131889103]
A call was received from the end user's wife stating that he had a pressure sore. She stated that he has trouble with sores, but that this one is much worse. She states that the cushions functionality was as expected, but it retains heat and she believes this is what caused his pressure sores to worsen. The end user lives in a hot and humid climate and he is usually seated for 15-18 hours per day.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1419507-2019-00001 |
| MDR Report Key | 8210643 |
| Report Source | CONSUMER |
| Date Received | 2019-01-02 |
| Date of Report | 2019-01-02 |
| Date of Event | 2018-11-01 |
| Date Mfgr Received | 2018-12-03 |
| Device Manufacturer Date | 2017-11-20 |
| Date Added to Maude | 2019-01-02 |
| 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 | 1501 S. 74TH STREET |
| Manufacturer City | BELLEVILLE IL 62223 |
| Manufacturer Country | US |
| Manufacturer Postal | 62223 |
| Manufacturer G1 | ROHO, INC. |
| Manufacturer Street | 1501 S. 74TH STREET |
| Manufacturer City | BELLEVILLE IL 62223 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 62223 |
| Single Use | 3 |
| Remedial Action | RL |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ROHO? QUADTRO SELECT? HIGH PROFILE? CUSHION |
| Generic Name | WHEELCHAIR CUSHION |
| Product Code | KIC |
| Date Received | 2019-01-02 |
| Model Number | QS910C |
| Operator | LAY USER/PATIENT |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ROHO, INC. |
| Manufacturer Address | 1501 S. 74TH STREET BELLEVILLE IL 62223 US 62223 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2019-01-02 |