MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a consumer report with the FDA on 2018-12-01 for ROHO? QUADTRO SELECT? HIGH PROFILE? CUSHION NSSS911C manufactured by Roho, Inc..
[129022390]
Roho, inc was notified of an alleged injury by the customer on 11/01/2018. After the initial notification, multiple attempts including phone calls and letters have been made to reach the customer, with no response. An investigation was performed on the device, and was found to be free of manufacturing defects. Per the investigation, post-delivery damage was discovered, which compromised the cushions ability to hold air. During the investigation it was confirmed that he was no longer residing at the care center. The report of an injury allegation has been documented, however we are unable to access medical records to confirm. If additional information is received, a follow-up report will be submitted.
Patient Sequence No: 1, Text Type: N, H10
[129022391]
Customer stated that he had surgery on an old sore and the cushion was given to him afterwards. At some point after beginning its use, he claimed that the front left quadrant went flat, but that the rear quadrants of the cushion were unaffected. He continued to sit on the cushion in its compromised state due to not having a replacement. He noticed the alleged injury upon standing and noticing blood on his towel. While expressing uncertainty, he believes this was the cause of his sore to reopen. Due to the alleged injury he sought treatment at a senior treatment care center.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1419507-2018-00006 |
| MDR Report Key | 8122250 |
| Report Source | CONSUMER |
| Date Received | 2018-12-01 |
| Date of Report | 2018-11-30 |
| Date of Event | 2018-10-01 |
| Date Mfgr Received | 2018-11-01 |
| Device Manufacturer Date | 2018-03-13 |
| 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 |
| 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 | 2018-12-01 |
| Returned To Mfg | 2018-11-19 |
| Model Number | NSSS911C |
| 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 STREET BELLEVILLE IL 62223 US 62223 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2018-12-01 |