MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 07 report with the FDA on 2013-08-06 for JAY EASY CUSHION FJE16-18 manufactured by Sunrise Medical.
[3823917]
Per dealer, claims that the fluid pad seams are rolling and will not lay flat. The dealer is alleging that this has caused the end user to develop a stage 2 pressure sore in the buttock region.
Patient Sequence No: 1, Text Type: D, B5
[11010480]
It appears that the wheelchair and/or parts involved in this incident are being returned to sunrise medical (us) llc. 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 | 9616084-2013-00004 |
| MDR Report Key | 3282567 |
| Report Source | 07 |
| Date Received | 2013-08-06 |
| Date of Report | 2013-07-08 |
| Date of Event | 2013-07-08 |
| Date Mfgr Received | 2013-07-08 |
| Date Added to Maude | 2013-08-13 |
| 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 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 | 3 |
| Brand Name | JAY EASY CUSHION |
| Generic Name | JAY CUSHION |
| Product Code | IMP |
| Date Received | 2013-08-06 |
| Model Number | FJE16-18 |
| Operator | LAY USER/PATIENT |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | SUNRISE MEDICAL |
| Manufacturer Address | PRIVADA MISIONES NO. 110 PARQUE INDUSTRIAL MISONES DE LAS CALIFORNIAS TIJUANA BAJA, CALIFORNIA 22425 22425 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2013-08-06 |