MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-04-12 for JAY XTREME ACTIVE CUSHION manufactured by Sunrise Medical Technologias.
[105371680]
The product in question is the jay xtreme active cushion. The rubber logo is sewn into the side of the cushion cover that sits below the rim of the cushion. This type of logo is used on covers for cushions that are manufactured and distributed in the united states as well; which is why this incident is being reported. This is the first time an incident of this kind has been reported to sunrise medical from any location world-wide. Since this cushion was not returned to sunrise medical, our quality team evaluated a similar cushion and attempted to duplicate the same effect without success that the end user is allegedly claiming is being caused by her cushion. The end user also claims that she does have feeling to the "bell" and thighs of her legs, however, kept using the cushion after several doctor visits even though it was allegedly causing the sores and scrapes. The end user has removed the logo from the cushion cover and has had no recurrence of the complaint. Sunrise medical's quality department will be performing an in depth assessment and monitor for trends. Sunrise medical's legal counsel is addressing her concerns and her claim. There will be no further investigation as there is no risk to public health identified.
Patient Sequence No: 1, Text Type: N, H10
[105371681]
The following complaint was received on (b)(6) 2018 from an end user in (b)(6): i have used your jay pillow with cover for 20 years and it has gone well. I got a new cover for the pillow and after about a month i got sores and skin scrapes on my left bell / thighs. I find out that when i moved from the bed to the chair, the bell and thighs scratch your new logo. Your new logo is made of stiff rubber, it destroys my skin and i have to spend days in the hospital. I am now full of ugly scars and it hurts very much.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9616084-2018-00003 |
| MDR Report Key | 7427404 |
| Date Received | 2018-04-12 |
| Date of Report | 2018-03-13 |
| Date of Event | 2018-03-13 |
| Date Mfgr Received | 2018-03-13 |
| Device Manufacturer Date | 2017-07-13 |
| Date Added to Maude | 2018-04-12 |
| 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 |
| Reporter Occupation | PATIENT |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MR. GUSTAVO ZAMBRANO |
| Manufacturer Street | 2842 BUSINESS PARK AVE. |
| Manufacturer City | FRESNO CA 93727 |
| Manufacturer Country | US |
| Manufacturer Postal | 93727 |
| Manufacturer Phone | 5592942840 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | JAY XTREME ACTIVE CUSHION |
| Generic Name | JAY CUSHION |
| Product Code | IMP |
| Date Received | 2018-04-12 |
| Model Number | JAY XTREME ACTIVE |
| Operator | LAY USER/PATIENT |
| Device Availability | N |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | SUNRISE MEDICAL TECHNOLOGIAS |
| Manufacturer Address | NO. 110 PARQUE INDUSTRIAL MISIONES DE LAS CALIFORNIAS TIJUANA, BAJA CALIFORNIA 22425 MX 22425 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization | 2018-04-12 |