MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative report with the FDA on 2018-12-01 for ROHO WHEELCHAIR CUSHION manufactured by Roho, Inc..
[129024261]
Roho, inc. Was notified of the alleged injury by the customer's legal counsel and is unable to contact the customer for additional information. The specific model of the device, serial number, and manufacturing date are unknown. Therefore, we are unable to review manufacturing records for the product. The device has not been returned so we cannot perform an investigation on the device itself. We've reviewed our existing complaints and found no other similar complaints on file. If we receive additional information, we will send a follow-up report. The customer claimed there was an injury. However, we are not able to access medical records to confirm.
Patient Sequence No: 1, Text Type: N, H10
[129024262]
Customer claims that the inflation valve on a roho product punctured him leading to an injury and bone infection that required two surgeries.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1419507-2018-00005 |
| MDR Report Key | 8122274 |
| Report Source | COMPANY REPRESENTATIVE |
| Date Received | 2018-12-01 |
| Date of Report | 2018-11-27 |
| Date Mfgr Received | 2018-10-31 |
| Date Added to Maude | 2018-12-01 |
| 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 | 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 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ROHO WHEELCHAIR CUSHION |
| Generic Name | WHEELCHAIR CUSHION |
| Product Code | KIC |
| Date Received | 2018-12-01 |
| 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. Hospitalization; 2. Other | 2018-12-01 |