MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a consumer report with the FDA on 2017-08-15 for ROHO? QUADTRO SELECT? HIGH PROFILE? CUSHION QS910C manufactured by Roho, Inc..
[82752161]
On the initial call, the patient's mother stated that she felt the cushion was not holding air, but that they had been unable to find a leak. Her son did not believe there was a problem with the cushion. They continued to use the cushion for a month before the wounds were noticed. Roho was unable to reproduce the described product failure during the evaluation of the device. The customer claimed hospitalization and surgery, however, roho has not seen any medical records to confirm this.
Patient Sequence No: 1, Text Type: N, H10
[82752162]
The patient's mother called to state that her son was in the hospital with four pressure injuries. Two are on the bottom lower part of his cheek, one is on his coccyx, and one is on the right side of his lower hip. He had surgery and needs 6 weeks of antibiotics. She stated the cushion he was using was not holding air and caused the injury.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1419507-2017-00001 |
| MDR Report Key | 6796448 |
| Report Source | CONSUMER |
| Date Received | 2017-08-15 |
| Date of Report | 2017-08-15 |
| Date of Event | 2017-07-13 |
| Date Mfgr Received | 2017-07-17 |
| Device Manufacturer Date | 2016-10-25 |
| Date Added to Maude | 2017-08-15 |
| 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 | 8008513449 |
| Manufacturer G1 | ROHO, INC. |
| Manufacturer Street | 1501 S. 74TH ST. |
| 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 | 2017-08-15 |
| Returned To Mfg | 2017-07-27 |
| Model Number | QS910C |
| Operator | LAY USER/PATIENT |
| Device Availability | R |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ROHO, INC. |
| Manufacturer Address | 1501 S. 74TH ST. BELLEVILLE IL 62223 US 62223 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization; 2. Required No Informationntervention | 2017-08-15 |