MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a consumer,health professional report with the FDA on 2015-09-24 for ROHO? QUADTRO SELECT? HIGH PROFILE? CUSHION QS109C manufactured by Roho, Inc..
[26634608]
The suspect product was not available for evaluation. During conversations with the complainant, the following was noted: because of his unique physiology, the complainant can't use a slide board to get in his wheelchair without tearing his skin. In order to get into his wheelchair, he gets on his right side and is completely sideways. He then pulls himself over the wheel and brake and into the seat. Since he is still sideways, he then has to hold onto the armrest and pull his body upright. The complainant stated he has used a seatbelt in the past to help prevent him from falling out of his wheelchair, but that it slides up to his stomach and pins him in place so he is stuck. He stated he does not use a chest strap. At the time of the event, the patient was using a basic dme wheelchair while waiting to be evaluated for a wheelchair that would be appropriate for his unique needs. The patient also stated he over-inflates his cushion as opposed to following roho's recommended inflation level because that is more comfortable for him. He stated that the break coming loose on the wheelchair and the wheelchair moving caused him to fall out of the wheelchair. The complainant stated that the roho cushion was not the contributing factor to this event. Based on communications with the complainant, roho has determined that the cushion did not malfunction in any way. Review of the dhr for the suspect product was conducted, and the cushion was found to be manufactured according the company specifications. During conversations with the complainant, roho representatives attempted to obtain the manufacturer's information associated with the manual wheelchair in question. The complainant was unable to provide this information.
Patient Sequence No: 1, Text Type: N, H10
[26634609]
Complainant stated that on (b)(6) 2015, he was pulling himself into a dme, sling seat manual wheelchair. The complainant stated that he was using a roho quadtro select high profile cushion at this time. When the complainant maneuvered into the chair, his body slid off of the cushion. As a result, the complainant's hip hit the brake on the wheelchair which caused the wheelchair to unlock and the complainant fell from the chair. The complainant sustained an unknown injury and was taken to the hospital.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1419507-2015-00003 |
| MDR Report Key | 5100611 |
| Report Source | CONSUMER,HEALTH PROFESSIONAL |
| Date Received | 2015-09-24 |
| Date of Report | 2015-09-17 |
| Date of Event | 2015-08-24 |
| Date Mfgr Received | 2015-09-01 |
| Device Manufacturer Date | 2015-06-10 |
| Date Added to Maude | 2015-09-24 |
| 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 | 8003562990 |
| Manufacturer G1 | ROHO, INC. |
| Manufacturer Street | 100 N. FLORIDA AVE. |
| Manufacturer City | BELLEVILLE IL 62221 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 62221 |
| Single Use | 3 |
| 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 | 2015-09-24 |
| Model Number | QS109C |
| Operator | LAY USER/PATIENT |
| Device Availability | N |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ROHO, INC. |
| Manufacturer Address | 100 N. FLORIDA AVE. BELLEVILLE IL 62221 US 62221 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization | 2015-09-24 |