MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-08-22 for ROHO manufactured by Roho, Inc..
[117959649]
The user indicated that the product did not fail, they were just displeased with the design and believe it contributed to an injury that will result in surgery. There was no additional information given in regards to the injury. There has also been no serial number, model number, or any other identifying information provided in order for roho to evaluate production and inspection records related to this product. Roho has attempted to contact the user multiple times by phone and email and has received no further information to aid in the investigation of this complaint.
Patient Sequence No: 1, Text Type: N, H10
[117959710]
A letter was received from business consumer alliance with the following information, "complaint description; i'm newly paraplegic and several doctor's suggest roho and it had better reviews than anyone else... Anyway that roho cushion damaged me bad... There is no air gage or way to tell if to much to little air... However that's not problem, the problem is it's design puts touch pressured on tail bones damaging me badly scared and i'm mad about it... Customer's desired settlement: fix my now surgery needed back end... It's hideous... No way anyone would be fine with this... Thanks for help. "
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1419507-2018-00002 |
| MDR Report Key | 7806965 |
| Date Received | 2018-08-22 |
| Date of Report | 2018-08-21 |
| Date Added to Maude | 2018-08-22 |
| 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 AVENUE |
| Manufacturer City | BELLEVILLE IL 62221 |
| Manufacturer Country | US |
| Manufacturer Postal | 62221 |
| Manufacturer Phone | 8008513449 |
| Manufacturer G1 | ROHO, INC. |
| Manufacturer Street | ROHO, INC. 1501 S. 74TH STREET |
| 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 | 0 |
| Brand Name | ROHO |
| Generic Name | WHEELCHAIR CUSHION |
| Product Code | KIC |
| Date Received | 2018-08-22 |
| 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 | ROHO, INC. 1501 S. 74TH STREET BELLEVILLE IL 62223 US 62223 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2018-08-22 |