MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2017-08-24 for ROHO? QUADTRO SELECT? CUSHION manufactured by Roho, Inc..
[83610169]
The caller stated that the nursing staff at the nursing home did not monitor the patient's skin as they should have. She stated that the nurses should have noticed any injury when they were bathing the patient or changing her clothes well before it is required hospitalization. She was concerned that the facility was blaming the injury on the cushion instead of following up with the nursing staff to ensure they were trained on proper usage of the cushion. The caller did not have access to the cushion in order to send it to roho for evaluation. She did not know the manufacturing date, cushion model, or serial number, so roho has been unable to perform a review of manufacturing records.
Patient Sequence No: 1, Text Type: N, H10
[83610170]
The caller stated a patient was in the hospital with a nearly stage iv pressure ulcer and needed a temporary colostomy because the wound was close to the anal outlet. She stated the nursing staff claimed the injury was caused after the patient sat on a roho quadtro select cushion with a flat quadrant for weeks.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1419507-2017-00003 |
| MDR Report Key | 6818745 |
| Report Source | HEALTH PROFESSIONAL |
| Date Received | 2017-08-24 |
| Date of Report | 2017-08-24 |
| Date of Event | 2017-01-01 |
| Date Mfgr Received | 2017-07-25 |
| Date Added to Maude | 2017-08-24 |
| 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 |
| Reporter Occupation | OCCUPATIONAL THERAPIST |
| 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 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ROHO? QUADTRO SELECT? CUSHION |
| Generic Name | WHEELCHAIR CUSHION |
| Product Code | KIC |
| Date Received | 2017-08-24 |
| Operator | HEALTH PROFESSIONAL |
| 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 ST. BELLEVILLE IL 62223 US 62223 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization | 2017-08-24 |