MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a other report with the FDA on 2016-05-12 for ROHO? ENHANCER? CUSHION ENHLGC manufactured by Roho, Inc..
[45092738]
Roho was first informed of the adverse event by (b)(6). The customer stated that the roho cushion was working properly and that he did not believe it was the cause of his injury. Since the roho cushion was not returned for evaluation, a review of the cushion's device history record was performed. This review showed the cushion was made according to the device master record specifications.
Patient Sequence No: 1, Text Type: N, H10
[45092739]
The customer received a new wheelchair and new roho wheelchair cushion. He stated there was a 4-5" gap between the back of the cushion and the back of the wheelchair after it was set up. He said he sat in the wheelchair for 2 weeks with the gap at the back of the chair. He claims this gap caused a "blood blister" on his back, which was located approximately 7-8" above his tailbone. After this, his brother removed the cushion part of the backrest (the part that is attached to backrest with velcro) and replaced it with the cushion part of the customer's old wheelchair backrest. This older backrest is longer than the one that came with his new wheelchair and filled in the gap between the cushion and the back of the wheelchair. The customer stated he doesn't know if the roho cushion fits properly in the seat pan or not, but it is working well. The customer told us he had surgery on the blood blister because his plastic surgeon stated it wouldn't heal on its own. He also stated, however, the blood blister was not bad enough to qualify him for reimbursement on the purchase of a low air mattress. He also stated the injury was healing now.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1419507-2016-00002 |
| MDR Report Key | 5651564 |
| Report Source | OTHER |
| Date Received | 2016-05-12 |
| Date of Report | 2016-05-12 |
| Date of Event | 2016-02-01 |
| Date Mfgr Received | 2016-04-15 |
| Device Manufacturer Date | 2016-01-21 |
| Date Added to Maude | 2016-05-12 |
| 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 IL 62223 |
| Manufacturer Country | US |
| Manufacturer Postal | 62223 |
| 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? ENHANCER? CUSHION |
| Generic Name | FLOTATION CUSHION |
| Product Code | KIC |
| Date Received | 2016-05-12 |
| Model Number | ENHLGC |
| 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 | 100 N. FLORIDA AVE. BELLEVILLE IL 62221 US 62221 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization | 2016-05-12 |