MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a distributor report with the FDA on 2018-06-22 for ROHO manufactured by Roho, Inc..
[112142624]
The device has not been returned so we have not been able to evaluate it. We do not have serial number to review device history record. The patient states that they required surgery and hospitalization. However, roho has not received medical records to confirm this. Roho is working with distributor to get additional information. If we do receive follow up information an additional report will be submitted. At that time, acknowledgements were received stating that the submission was received. However, after some months now it has become evident that the submission failed due to a typo in the manufacturer's report number. Instead of "(b)(4)", it should have been "(b)(4)".
Patient Sequence No: 1, Text Type: N, H10
[112142625]
Patient stated, "on the (b)(6), suddenly, the pillow deflated, i did not notice it immediately. I was sitting 3 hours and then i went to bed. I am very scrupulous and careful to check that the pillow is always swollen to the right extent. The deflation of the pillow, in such a short time, caused me tissue injury to the left ischial tuberosity. It's very deep! With the treatments that the nurses of (b)(6)'s local health unit are doing to me, the wound does not heal. Unfortunately, i will have to do a surgery that involves six weeks of hospitalization, and then another two months in bed at home. "
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1419507-2017-00007 |
| MDR Report Key | 7630747 |
| Report Source | DISTRIBUTOR |
| Date Received | 2018-06-22 |
| Date of Report | 2017-11-22 |
| Date of Event | 2017-06-20 |
| Date Mfgr Received | 2017-10-27 |
| Date Added to Maude | 2018-06-22 |
| 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 AVE. |
| Manufacturer City | BELLEVILLE IL 62221 |
| Manufacturer Country | US |
| Manufacturer Postal | 62221 |
| 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 |
| Generic Name | WHEELCHAIR CUSHION |
| Product Code | KIC |
| Date Received | 2018-06-22 |
| 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 | 1501 S. 74TH STREET BELLEVILLE IL 62223 US 62223 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization | 2018-06-22 |