MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 07 report with the FDA on 2014-09-08 for JAY UNION CUSHION JU2018 manufactured by Sunrise Medical Privada Misiones.
[4703652]
An adverse event involving a jay union cushion was reported to sunrise medical on (b)(6) 2014. The dealer reported that the end-user is bottoming out on the cushion. As a result, the end-user has developed stage 2 pressure sores near the ischial region of their bottom.
Patient Sequence No: 1, Text Type: D, B5
[12410931]
A good faith effort was made to obtain all required info for the filing of this mdr. However, the end-user's gender and age has not been provided at the time of this filing. If and when the required info is obtained, it will be submitted in a supplemental mdr. It appears that the wheelchair and/or parts involved in this incident are being returned to sunrise medical. If and when the chair/parts are received, our internal failure investigator will complete the investigation and a follow up report will be filed.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 9616084-2014-00003 |
| MDR Report Key | 4109289 |
| Report Source | 07 |
| Date Received | 2014-09-08 |
| Date of Report | 2014-08-21 |
| Date of Event | 2014-08-21 |
| Date Mfgr Received | 2014-08-21 |
| Device Manufacturer Date | 2012-08-01 |
| Date Added to Maude | 2014-09-24 |
| 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 | 0 |
| Event Location | 0 |
| Manufacturer Contact | JEREMY YBARRA, SPECIALIST |
| Manufacturer Street | 2842 BUSINESS PARK DR. |
| 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 | 3 |
| Brand Name | JAY UNION CUSHION |
| Generic Name | JAY CUSHION |
| Product Code | IMP |
| Date Received | 2014-09-08 |
| Model Number | JU2018 |
| Operator | LAY USER/PATIENT |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | SUNRISE MEDICAL PRIVADA MISIONES |
| Manufacturer Address | NO.110 PARQUE INDUSTRIAL MISIONES DE LAS CALIFORNIAS TIJUANA, BAJA CA 22425 US 22425 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2014-09-08 |