MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a consumer report with the FDA on 2017-09-11 for ROHO? NEXUS SPIRIT? CUSHION NS1717C manufactured by Roho, Inc..
[85588660]
The patient did not claim the device was malfunctioning. He only stated that the cushion was too small and that this is what led to the injury. Roho, inc. Made several attempts to contact the patient in order to obtain additional information for this report, however, the patient did not reply. Roho, inc. Has not seen any medical records and can therefore not confirm the claim of injury.
Patient Sequence No: 1, Text Type: N, H10
[85588661]
Patient contacted roho, inc. By telephone stating he has breakdown on his bottom. Patient also claims that he is confined to his bed because of the breakdown and needs a different cushion. He also contacted our sales rep by text stating he had an open pressure sore on his tailbone and that the skin on his back and rear are scarred from the numerous pressure sores he has received.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1419507-2017-00004 |
| MDR Report Key | 6854237 |
| Report Source | CONSUMER |
| Date Received | 2017-09-11 |
| Date of Report | 2017-09-08 |
| Date of Event | 2017-08-10 |
| Date Mfgr Received | 2017-08-10 |
| Device Manufacturer Date | 2017-01-20 |
| Date Added to Maude | 2017-09-11 |
| 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? NEXUS SPIRIT? CUSHION |
| Generic Name | WHEELCHAIR CUSHION |
| Product Code | KIC |
| Date Received | 2017-09-11 |
| Model Number | NS1717C |
| 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 ST. BELLEVILLE IL 62223 US 62223 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2017-09-11 |