MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign,health professional report with the FDA on 2018-06-22 for ROHO QS99C manufactured by Roho, Inc..
[112144366]
Roho has translated the content of the report and attempted to contact personnel at the facility that originally reported the incident to aid in the investigation. However at this time, there has been no response. The facility report stated that the product was not correctly applied. As of today, with the information provided in the report, roho does not consider this to be an incident (reportable event), since a use error is clearly indicated in the report with the confirmation that "there is nothing wrong with the product" (reference to meddev 2. 12-1 rev. 8 clause 5. 2). The serial number provided in the facility report does not meet the format of serial numbers used for roho products and therefore, the manufacturer cannot evalutate production and inspection records related to this product. There was also no further information given in regards to the injury. The injuries for a person not using a cushion are known and the injury experienced by the patient may be of similar nature. Roho is continuing to attempt contact in order to determine the full nature of the damage. There is conflicting information in the facility report, as it indicated that the product was both sent back to the distributor and that it was kept at the facility. Therefore, as part of the investigation, roho will attempt to determine where the product is currently located and request that it be returned to roho for evaluation.
Patient Sequence No: 1, Text Type: N, H10
[112144367]
When visiting (b)(6), the rehab staff discovered that the cover of the cushion was put on in a wrong way so that the chairprotection was upside-down"
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1419507-2018-00001 |
| MDR Report Key | 7630990 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL |
| Date Received | 2018-06-22 |
| Date of Report | 2018-04-12 |
| Date of Event | 2017-08-22 |
| 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 |
| Remedial Action | OT |
| 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 |
| Model Number | QS99C |
| 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. Other | 2018-06-22 |