MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a consumer report with the FDA on 2015-10-29 for ROHO? HYBRID ELITE? SINGLE COMPARTMENT CUSHION 1RHY1517C manufactured by Roho, Inc..
[29787783]
The customer stated that he did not contact roho until two weeks after he started noticing problems with the cushion. The customer claimed he had a pressure ulcer, however, roho has not seen any medical records to confirm the diagnosis. The claim that only one side of the cushion was losing air is unusual. Roho spoke with the customer and asked that the suspect cushion be returned for evaluation. A shipping label was provided via email as requested so the cushion could be returned, but as of the date of this report, there is no tracking information and the cushion has not been sent back for evaluation. Since the cushion has not been returned for evaluation, roho has reviewed the dhr records and confirmed the 1rhy1517c, serial number (b)(4), was manufactured according to the device master record specifications. The customer was sent a replacement cushion and has stated the new cushion is working and he has had no problems.
Patient Sequence No: 1, Text Type: N, H10
[29787784]
The customer called and stated the right side of his cushion would not hold air and that it caused a pressure sore. He stated he first tried to find a leak in the cushion and used the repair kit that came with the cushion. He stated he had seen a doctor and that they took x-rays and performed a ct scan and there was nothing wrong with his body. The customer said his doctor stated the cushion caused the sore. In a subsequent conversation with the customer, he stated he had been in the hospital for a couple of days due to problems with his back and spine. He thinks the back and spine problems were caused at least partly because he was sitting wrong as a result of the pressure sore.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1419507-2015-00007 |
| MDR Report Key | 5186342 |
| Report Source | CONSUMER |
| Date Received | 2015-10-29 |
| Date of Report | 2015-10-27 |
| Date of Event | 2015-09-01 |
| Date Mfgr Received | 2015-09-28 |
| Device Manufacturer Date | 2014-11-17 |
| Date Added to Maude | 2015-10-29 |
| 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? HYBRID ELITE? SINGLE COMPARTMENT CUSHION |
| Generic Name | WHEELCHAIR CUSHION |
| Product Code | KIC |
| Date Received | 2015-10-29 |
| Model Number | 1RHY1517C |
| 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 | 2015-10-29 |