MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a consumer report with the FDA on 2018-10-04 for ROHO? HIGH PROFILE? SINGLE COMPARTMENT CUSHION 1R109C manufactured by Roho, Inc..
[122799061]
The returned cushion cover was evaluated. The patient's husband claims that her hip was broken, however roho, inc. Did not receive medical records to confirm this. He also noted that his wife leaned forward while the wheelchair brakes were off, which was likely a contributing factor to the fall. There was no claim that the cover was damaged, only that it was "slick. " the cushion cover is intentionally designed with a top material that does not increase shear or inhibit immersion in the air cells so the patient can maximize the tissue protection benefits of the cushion. An email has been sent to the wheelchair manufacturer that was identified during our complaint investigation. If roho, inc. Receives any additional information related to this event, a follow up report will be submitted. (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[122799062]
The patient was placing things on top of a lower piece of furniture in the dining room. She had her brakes on so she couldn't move forward. She wanted to back up so that she could turn around and leave the room and go back into the kitchen. In order to do so she took her brake off. While attempting to reverse, the chair went backward and she fell forward out of the chair. On a follow up call, the patient's husband stated that his wife was in rehab and will be coming home tomorrow. He stated that she may have been positioning her center of gravity closer to the front of the chair since she was placing things on top of the dresser when the incident occured. He felt that the cover contributed to her slipping out of the chair when the chair rolled backward. Before using the cushion at home, he stated that it was used with a towel in between his wife and the cover/cushion. He stated that his wife's hip was broken just below the ball at the top of the femur and that surgery and hospitalization were required.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1419507-2018-00004 |
| MDR Report Key | 7935778 |
| Report Source | CONSUMER |
| Date Received | 2018-10-04 |
| Date of Report | 2018-10-04 |
| Date of Event | 2018-08-18 |
| Date Mfgr Received | 2018-09-05 |
| Device Manufacturer Date | 2017-11-01 |
| Date Added to Maude | 2018-10-04 |
| 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 ST. |
| Manufacturer City | BELLEVILLE 62223 |
| Manufacturer Country | US |
| Manufacturer Postal | 62223 |
| Manufacturer Phone | 6182228363 |
| Manufacturer G1 | ROHO, INC. |
| Manufacturer Street | 1501 S. 74TH ST. |
| Manufacturer City | BELLEVILLE 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? HIGH PROFILE? SINGLE COMPARTMENT CUSHION |
| Generic Name | WHEELCHAIR CUSHION |
| Product Code | KIC |
| Date Received | 2018-10-04 |
| Returned To Mfg | 2018-09-28 |
| Model Number | 1R109C |
| Lot Number | 04/19/2018 |
| 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 ST. BELLEVILLE 62223 US 62223 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization | 2018-10-04 |