MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a consumer report with the FDA on 2015-12-02 for ROHO? QUADTRO SELECT? HIGH PROFILE? CUSHION QS99C manufactured by Roho, Inc..
[32567858]
Roho has sent the customer a replacement 18" x 20" cushion to use along with a return label so the 18" x 18" cushion could be evaluated. Please see the attached evaluation summary. The expected life of a roho cushion is three years based on testing and evaluation of the product. Based on the end user's claim, his cushion (serial number (b)(4)) was manufactured in 2007 and was therefore being used out of the expected life of such cushions. Roho's product support policy allows for a three year warranty period on the quadtro select cushion line. The customer claimed he had a pressure ulcer, however, roho has not seen any medical records to confirm the diagnosis.
Patient Sequence No: 1, Text Type: N, H10
[32567859]
The customer stated his 18" x 20" roho cushion was soiled and he used a spare roho cushion that is 18" x 18". His wheelchair seat is 18" x 20". The customer stated that after he adjusted his 18" x 18" roho quadtro select cushion and locked the isoflo memory control, the air did not stay locked in the four quadrants. Instead, air moved from the back of the cushion to the front of the cushion. The customer stated he developed a stage ii pressure ulcer that was approximately 3 cm x 6 cm. He first went to a wound care clinic that he has been to in the past, but their treatment plan was not working. The customer then went to a hospital and had outpatient care. His certified wound care nurse is coordinating the treatment plan with the hospital and the pressure ulcer is now closed up. The customer is currently only supposed to sit for an hour at a time and then has to check his skin for redness.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1419507-2015-00008 |
| MDR Report Key | 5262237 |
| Report Source | CONSUMER |
| Date Received | 2015-12-02 |
| Date of Report | 2015-12-02 |
| Date of Event | 2015-08-01 |
| Date Mfgr Received | 2015-11-03 |
| Device Manufacturer Date | 2014-07-16 |
| Date Added to Maude | 2015-12-02 |
| 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 |
| Remedial Action | RL |
| 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 | 2015-12-02 |
| Returned To Mfg | 2015-11-30 |
| Model Number | QS99C |
| 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 | 100 N. FLORIDA AVE. BELLEVILLE IL 62221 US 62221 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2015-12-02 |