MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a consumer report with the FDA on 2019-10-21 for ROHO? QUADTRO SELECT? LOW PROFILE? CUSHION QS910LPC manufactured by Roho, Inc..
[163122954]
The fianc? Of the end user alleges that he has developed a large pressure injury following the extended use of a deflated cushion. Per the finance, his cushion went flat while the family was travelling, and once he advised them, they were unable to determine why-so a "bed pillow was cut up" and used to raise the deflated area of the cushion until they arrived back home. Reportedly, the end user has a history of receiving pressure injuries, noting that this is his 3rd one. The caller states that the end user has a hard time finding a cushion that works for him properly. It is reported that the end user was hospitalized due to an infection and a fever of 103. 3, while also having a pressure injury. The caller is unsure about how long the end user was sitting on the deflated cushion due to the end user being secretive about his self-care. Recently, it was confirmed that the end user is home, and that they have stabilized per physicians. The caller states that the end user has a hard time finding a cushion that works for him properly, and that he feels the immersion function of the current cushion makes him sink in too much. It was suggested that the end user see a seating specialist as soon as possible to ensure that positioning is appropriate. A replacement cushion was sent to the caller and a return label was given so that the cushion of concern could be evaluated. As of 10/18, the cushion has not been received. Per caller, daily hand checks as detailed in the manual, were not being conducted. The end user is replacing his wheelchair and has arranged for a seating specialist to come out to ensure that the chair is a proper fit for him, and then to complete the initial set up of the replacement cushion that was received. Subsequent check-ins with the caller have all returned positive progress notes, and the end user continues to offload throughout the day until consultation with the seating specialist has occurred. Although an alleged injury is reported, no medical documents have been submitted for confirmation. A dhr review is being conducted and information will be added to the physical complaint file. If additional contact is made with the end user or if additional information is obtained, then the information provided will be updated. Initial submission attempt was made on friday, october 21st. However, due to technical difficulties the esg helpdesk was needed. Response from the esg helpdesk occured on monday, october 21st, and so report was submitted.
Patient Sequence No: 1, Text Type: N, H10
[163122955]
Customer's fianc? Called in and stated that their family went on vacation. The cushion allegedly went flat, and the end user didn't say anything initially and continued to use the cushion. Once it was discovered, the fianc? Cut up a pillow and placed the pieces under the end user since the back quads of the cushion were not holding air. End user was taken to the hospital upon arriving home. Fianc? Stated that end user had a big pressure sore and a 103. 3-degree fever.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1419507-2019-00005 |
| MDR Report Key | 9215715 |
| Report Source | CONSUMER |
| Date Received | 2019-10-21 |
| Date of Report | 2019-10-18 |
| Date of Event | 2019-09-19 |
| Date Mfgr Received | 2019-09-19 |
| Device Manufacturer Date | 2018-08-27 |
| Date Added to Maude | 2019-10-21 |
| 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 | MRS. ROBIN GERGEN |
| Manufacturer Street | 1501 S. 74TH STREET |
| Manufacturer City | BELLEVILLE IL 62223 |
| Manufacturer Country | US |
| Manufacturer Postal | 62223 |
| Manufacturer Phone | 8008513449 |
| 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? LOW PROFILE? CUSHION |
| Generic Name | WHEELCHAIR CUSHION |
| Product Code | KIC |
| Date Received | 2019-10-21 |
| Returned To Mfg | 2019-10-30 |
| Model Number | QS910LPC |
| Operator | LAY USER/PATIENT |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| 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. Hospitalization; 2. Other | 2019-10-21 |