MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 07 report with the FDA on 2013-06-21 for JAY CUSHION F2477 manufactured by Sunrise Medical Technolgias S.a. De Cv.
[17444365]
Per (b)(6) (dealer), claims that the end user has developed pressure sores in the buttocks area. The severity of the pressure sores are unk at this time.
Patient Sequence No: 1, Text Type: D, B5
[17743274]
This cushion was sold to an end user overseas, and it is unk at this time if the cushion will be returned to sunrise medical for an eval. If and when the product is returned, a quality specialist will investigate the cushion and a supplemental report will be filed.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 9616084-2013-00003 |
| MDR Report Key | 3188251 |
| Report Source | 07 |
| Date Received | 2013-06-21 |
| Date of Report | 2013-05-23 |
| Date of Event | 2013-05-23 |
| Date Mfgr Received | 2013-05-23 |
| Date Added to Maude | 2013-06-26 |
| 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, RA, QA SPECIALIST |
| Manufacturer Street | 2842 BUSINESS PARK AVE |
| Manufacturer City | FRESNO CA 93727 |
| Manufacturer Country | US |
| Manufacturer Postal | 93727 |
| Manufacturer Phone | 5592942840 |
| Manufacturer G1 | SUNRISE MEDICAL TECHNOLGIAS S.A. DE CV |
| Manufacturer Street | PRIVADA MISIONS #110 PARGUE INDUCATRIAL MISIONES |
| Manufacturer City | TIJUANA, B.C. |
| Manufacturer Country | MX |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | JAY CUSHION |
| Generic Name | JAY 2 DEEP CONTOUR CUSHION |
| Product Code | IMP |
| Date Received | 2013-06-21 |
| Model Number | F2477 |
| 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 TECHNOLGIAS S.A. DE CV |
| Manufacturer Address | PRIVADA MISIONS #110 PARGUE INDUCATRIAL MISIONES TIJUANA, B.C. MX |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2013-06-21 |